Bon Charge - Product Manual Compliance Reference

Extracted: 2026-04-25 Purpose: Marketing agency compliance reference - exact manual language, TH vs non-TH split

PRODUCT 1: RED LIGHT TOOTHBRUSH

Version split

Key signal: The TH manual carries a "For use when not connected to the mains voltage" symbol unique to medical device labelling. The non-TH does not. Both are V1.0 July 2025.

1A. NON-TH VERSION - Indications for use (exact wording)

• "For daily maintenance of oral hygiene"
• "To support healthy teeth and gums as part of a regular brushing routine"
• "To gently stimulate and massage gums with near-infrared and red light and sonic vibration."

Device description (exact wording): "The BON CHARGE Red Light Toothbrush combines high-frequency sonic vibration with red light (660 nm) and near-infrared (830 nm) to enhance oral hygiene and support gum care."

"Depending on the selected mode, the toothbrush is engineered to deliver sonic vibration with the benefits of near-infrared and red light, offering effective cleaning and gentle gum stimulation."

1B. TH VERSION - Indications for use (exact wording)

All non-TH indications PLUS the following additional therapeutic claims:

• "Supports recovery of soft tissues in the oral cavity following dental procedures"
• "Aids in the management of gingival inflammation."
• "Promotes healing of oral soft tissue by stimulating circulation."
• "Helps reduce symptoms associated with mild periodontitis."
• "May reduce gum bleeding and soreness associated with minor gingival conditions"

Device description: Identical to non-TH version.

Permitted benefit claims by version

Non-TH - safe to claim (derived directly from IFU):

• Daily maintenance of oral hygiene
• Supports healthy teeth and gums as part of a regular brushing routine
• Gently stimulates and massages gums with near-infrared and red light and sonic vibration
• Effective cleaning and gentle gum stimulation
• Enhances oral hygiene and supports gum care

TH - additional claims permitted (above non-TH list PLUS):

• Supports recovery of soft tissues in the oral cavity following dental procedures
• Aids in the management of gingival inflammation
• Promotes healing of oral soft tissue by stimulating circulation
• Helps reduce symptoms associated with mild periodontitis
• May reduce gum bleeding and soreness associated with minor gingival conditions

Forbidden for non-TH markets (claims only in TH IFU):

• Any reference to periodontitis, gingival inflammation management, post-dental procedure recovery, or healing of oral soft tissue
• Any language implying therapeutic treatment of a diagnosed condition

Disclaimer (exact wording - both versions identical)

"This product is not intended to diagnose, cure or prevent any disease. BON CHARGE makes no claims, representations or warranties regarding the ability of this product to cure any physical ailments. A qualified Healthcare Professional should be consulted with regard to any condition requiring medical attention."

Contraindications - who MUST NOT use (both versions identical - exact wording)

"DO NOT use the device if:

• You have active cancer or a cancerous lesion
• You have known allergies to light, plastic, or metal
• You are taking medication that causes photosensitivity
• You have a light-induced headache history
• You suffer from epilepsy or seizures triggered by light
• You suffer from any photosensitive disorder (sensitization to light)"

Warnings (both versions identical - exact wording)

• "STOP use and consult a healthcare professional if you experience discomfort, irritation, dizziness, or other adverse reactions"
• "DO NOT stare at light source or direct light onto the eyes. This may cause temporary loss of sight."
• "DO NOT use over open wounds or infected areas"
• "DO NOT use if device is damaged, dropped, or malfunctioning"
• "ONLY use accessories supplied or approved by the manufacturer"
• "DO NOT attempt to repair, modify, or disassemble - no serviceable or replaceable parts inside"
• "DO NOT submerge in water or charge near water"
• "DO NOT use if you've had recent oral surgery or are recovering from infection, as this may result in the worsening of symptoms."
• "DO NOT use the device in any other way than specified in this manual."

Important safety information (both versions identical - exact wording)

• "Keep out of reach of children."
• "Do not chew or bite the brush."
• "Use only for cleaning teeth, gums, and tongue."
• "Avoid shining light directly into the eyes."
• "Consult a healthcare professional if you experience discomfort."
• "Fully charge the toothbrush before first use."
• "Do not use the device or accessories if damaged."
• "Consult your dental professional before use if you have oral health concerns."
• "Each family member should use their own toothbrush and brush head."

Session duration and frequency

• Session duration: 2-minute smart timer (dentist recommended)
• 30-second interval pause to prompt switching between quadrants of the mouth
• Battery life: "Lasts up to 4 weeks with twice-daily 2-minute use"
• No explicit upper limit on daily session frequency stated; implied twice-daily from battery spec

Brushing modes (both versions identical)

Light: 3 x Red Light LEDs (660nm) + 3 x Near-Infrared LEDs (830nm) = 6 LEDs total

Adverse effects note (both versions identical - exact wording)

"Note: Some users may experience slight gum bleeding during initial use. This usually resolves in a few days. If bleeding continues after two weeks, consult your dentist or healthcare professional."

Light sensitivity test (both versions identical - exact wording)

"Before using your toothbrush for the first time, we recommend conducting a sensitivity test to check for any potential issues.

1. Place device just above your inner forearm
2. Turn on and leave in position for 10 minutes.
3. If discomfort occurs, stop use immediately
4. Observe the skin over the next 24 hours a. If redness or irritation occurs, do not use the device b. Consult your healthcare professional"

Key differences summary - Toothbrush TH vs non-TH

PRODUCT 2: RED LIGHT CAP

Version split

Both V1.0, August 2025.

2A. BOTH VERSIONS - Indications for use (exact wording - identical across TH and non-TH)

"The BON CHARGE Red Light Cap is designed to deliver red LED light to capillary hair follicles to stimulate hair growth and promote thicker, healthier-looking hair. With easy and convenient home use, this cap stimulates the scalp and encourages natural hair follicle activity to promote hair growth in men and women."

Non-TH adds only: "The Red Light Cap is suitable for skin types I-IV on the Fitzpatrick Skin Types Scale (See Figure 1)."

TH adds (instead of non-TH closing line): "Ideal for men with hair thinning patterns (IIa-V on the Hamilton-Norwood Scale, Figure 1) and women with thinning patterns (I-1 to I-4, II-1, II-2, or frontal patterns on the Ludwig-Savin Scale, Figure 2), the Red Light Cap is suitable for skin types I-IV on the Fitzpatrick Skin Types Scale (See Figure 3)."

Key difference: TH version explicitly references clinical hair thinning classification scales

• TH only: References Hamilton-Norwood Scale (male pattern hair thinning, IIa-V)
• TH only: References Ludwig-Savin Scale (female pattern hair thinning, I-1 to I-4, II-1, II-2, frontal patterns)
• Both: Fitzpatrick Skin Types Scale I-IV eligibility
• Both: "stimulate hair growth," "promote thicker, healthier-looking hair," "encourage natural hair follicle activity"

2B. Device description (both versions - exact wording, identical)

"The BON CHARGE Red Light Cap is an over-the-counter (OTC), user-friendly device designed for at-home use to help stimulate capillary hair growth in both men and women. It delivers red light (650nm) from LEDs across the entire scalp and is ideal for quick, daily 10-minute sessions to support fuller hair. Thoughtfully designed with a soft textile exterior, integrated LED circuit, rechargeable battery, and a simple one-button controller, this lightweight, hands-free cap is non-invasive and easy to use anywhere."

Permitted benefit claims by version

Both TH and non-TH - safe to claim:

• "deliver red LED light to capillary hair follicles to stimulate hair growth"
• "promote thicker, healthier-looking hair"
• "stimulates the scalp and encourages natural hair follicle activity to promote hair growth in men and women"
• "help stimulate capillary hair growth in both men and women"
• "support fuller hair"
• Non-invasive, hands-free, at-home use

TH only - additional specificity permitted:

• Referencing specific hair thinning pattern stages (Hamilton-Norwood IIa-V for men; Ludwig-Savin I-1 to I-4, II-1, II-2, frontal for women)
• Targeting language tied to clinically defined hair thinning patterns

Non-TH - what to avoid:

• Do not reference specific hair loss classification scales or pattern staging in non-TH markets
• Do not frame as treatment for a diagnosed hair loss condition (androgenetic alopecia, etc.)

Disclaimer (both versions - exact wording)

TH version (bolded in original): "This product is not intended to diagnose, cure or prevent any disease. BON CHARGE makes no claims, representations or warranties regarding the ability of this product to cure any physical ailments. A qualified Healthcare Professional should be consulted with regard to any condition requiring medical attention."

Non-TH version (not bolded in original): "This product is not intended to diagnose, cure or prevent any disease. BON CHARGE makes no claims, representations or warranties regarding the ability of this product to cure any physical ailments. A qualified Healthcare Professional should be consulted with regard to any condition requiring medical attention."

Contraindications - who MUST NOT use (both versions - exact wording, identical)

"DO NOT use the device if:

• You are 18 years old or younger
• You are pregnant, planning on becoming pregnant, or breastfeeding
• You have cancer or are undergoing cancer treatment
• You have light-sensitive conditions, seizures, epilepsy, or light-induced headaches.
• You are allergic to non-latex rubber, plastics, fabrics, or metals
• You are taking medications (e.g. tetracyclines) that increase or cause light sensitivity
• You have conditions like phlebitis (inflammation of veins), thrombophlebitis (blood clots resulting in inflammation of veins), or varicose veins
• You recently had surgery or other surgical procedures unless otherwise instructed by your healthcare professional
• You have a fever, acute inflammation, a severe circulatory disorder, anesthetized, or desensitized areas"

Note (both versions - exact wording): "Always consult your healthcare professional before use if you are undergoing treatment for any acute or chronic condition, or unsure about your health or medications."

Warnings - DO NOT (both versions - exact wording, identical)

• "Let children play with, recharge or clean the device"
• "Shine LEDs directly into eyes as this may cause temporary loss of eyesight"
• "Use on ANY open wounds as this may result in the worsening of symptoms"
• "Use it on rosacea (redness), open sores, or cancerous lesions"
• "Use on moles, warts, or on ANY skin condition"
• "Use on painful areas"
• "Machine wash or submerge the cap in water as this will damage the device"
• "Use or store near hot or wet surfaces"
• "Use or store in extreme heat or cold conditions"
• "Use if the device or cable is damaged"
• "Use if the device is overheating and turn it off immediately"
• "Use if your skin feels uncomfortably warm"
• "Drop, modify, open, or insert any objects into any openings of the device"
• "Sit on, lie on, or step on the device as this will break the device"
• "Use with unapproved accessories"
• "Use any solvents or abrasive cleaners"
• "Use in any way other than what is specified in this manual"
• "Use the device with any USB-C to USB-A cable other than the one provided"

Important safety information (both versions - exact wording, identical)

• "Keep out of reach of children"
• "If you have any health concerns, consult a healthcare professional before use"
• "Avoid shining light directly into the eyes, or looking directly at the LEDs"
• "Fully charge before first use"
• "Do not use if damaged"
• "Only use on clean and dry hair/scalp"
• "Intended for individual use. For hygiene reasons it is not recommended that the Red Light Cap is shared with other users."
• "DO NOT use on irritated, or wounded skin or on any skin conditions"
• "Intended for use on the human scalp ONLY"
• "Warranty will be null and void if not operated in accordance with the instructions"

Stop using if you notice (both versions - exact wording):

• "Any form of discomfort"
• "The device feels too warm"
• "Your skin feels uncomfortably warm"
• "The efficacy of this device has not been clinically tested in individuals with skin type ranges from V - VI in the Fitzpatrick Skin Types Scale"

Session duration and frequency

• Full session time: 10 minutes (auto-shutoff)
• Recommended use: Once in 24 hours (NOTE from manual: "It is not recommended to use the device more than once a day.")
• Recommended course: "Use once daily for 2-3 months for best results." (both versions)
• Charging time: 4 hours

Adverse reactions (both versions - exact wording, identical)

Temporary side effects: "Immediately after use, the skin may appear red and should return to normal within 1-2 hours."

"Temporary mild headaches might occur immediately following use. If required, this can be treated with an appropriate OTC pain killer and rehydration."

Rare side effects - stop use and consult healthcare professional if:

• "Discomfort, skin discoloration, skin irritation or other skin concerns"
• "Hypotension, nausea, dizziness or light-headedness"
• "Bruising or contact burns"

"IMPORTANT: If you experience any persistent discomfort during or after use, stop using the device and consult your healthcare professional."

Light sensitivity test (both versions - exact wording, identical)

"Before your first use, we recommend you do a light sensitivity test to check for any potential issues:

• Place the cap on your inner forearm
• Turn it on for a 10-minute session
• If it feels hot or uncomfortable, stop immediately
• After the session, remove the cap and wait 24 hours
• If redness or irritation occurs, DO NOT use the device
• Consult your healthcare professional"

Technical parameters (both versions - identical)

Skin type eligibility (both versions)

Suitable for: Fitzpatrick Skin Types I-IV Note in both manuals: "The efficacy of this device has not been clinically tested in individuals with skin type ranges from V - VI in the Fitzpatrick Skin Types Scale"

Key differences summary - Red Light Cap TH vs non-TH

CROSS-PRODUCT RULES: WHAT APPLIES TO BOTH PRODUCTS

Universal rules from manuals

1. Disclaimer must never be softened: "This product is not intended to diagnose, cure or prevent any disease."

2. Eye safety: Never imply the devices can be pointed at eyes. Both manuals: "DO NOT stare at light source or direct light onto the eyes. This may cause [temporary loss of sight / temporary loss of eyesight]."

3. Open wounds: Never imply products can be used on open wounds, infected areas, sores, rosacea, cancerous lesions, moles or warts.

4. Cancer absolute exclusion: Both products exclude users with active cancer or cancerous lesions / cancer treatment. This cannot be softened in any marketing claim.

5. Photosensitivity exclusion: Both products exclude users with epilepsy/seizures triggered by light, photosensitive disorders, light-induced headaches, or photosensitising medications.

6. Children: Neither product is for use by or near children.

7. Fitzpatrick types V-VI: Efficacy not clinically tested in Types V-VI. Neither product should be marketed to or imply suitability for darker skin types.

8. Individual use only: Both products are for individual use only.

9. Pregnant/breastfeeding exclusion: Stated explicitly for the Cap (both versions). Not stated for Toothbrush but general "consult healthcare professional before use if you have oral health concerns" applies.

10. Recent surgery: Toothbrush - "DO NOT use if you've had recent oral surgery or are recovering from infection." Cap - "You recently had surgery or other surgical procedures" is a contraindication.

MARKETING CLAIM RISK MATRIX

NOTES FOR CONTENT AND CS TEAMS

• The distinction between TH and non-TH is market-level, not product-level. The physical device is the same; the IFU (instructions for use) differs by market.
• For non-TH markets (AU, UK, EU): all therapeutic condition language in the TH IFU is out of bounds. Stick to the 3 non-TH indications for the Toothbrush and the general hair growth/thicker hair language for the Cap.
• For TH markets (US): the expanded indications are available but the disclaimer still applies. The product is still not a diagnostic or cure.
• The Cap contraindications are significantly more extensive than the Toothbrush contraindications. CS responses for the Cap should always route pregnancy, cancer, phlebitis, thrombophlebitis, post-surgery, and photosensitivity questions to healthcare provider advice.
• Both products carry the Fitzpatrick Skin Type V-VI efficacy caveat. This is a marketing boundary as well as a safety one.
• Both products are OTC (over-the-counter) devices, not prescription medical devices.