Active Ingredient
Phthalimidoperoxycaproic Acid(PAP) 12%
Teeth Whitening Strips
FDA Label NDC 83812-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Llrn Personal Care(shenzhen)co., Ltd for the product Teeth Whitening Strips (NDC 83812-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Teeth Whitening
Use
Teeth stains from coffee, tobacco, genetic, tetracycline, food coloring, aging and other factors that may cause discoloration.
Warnings
1. Not intended for children under 16.
2. Do not swallow strip.
3. Avoid contact of strips with eyes or skin.
4. If the strip comes into contact with skin, it may cause temporary skin irritation.
5. If there is any discomfort, please stop using and consult a dentist immediately
6. Not suitable for people who have ulcers, exposed gums or after oral surgery.
Do Not Use
Not intended for children under 16.
Not suitable for people who have ulcers, exposed gums or after oral surgery.
When Using
1. Avoid using strips after brushing your teeth. Allow at least one hour after brushing teeth before using the strips.
2. Do not re-use the strips, please dispose of once used.
3. The ingredients of the strips are safe and if some gel is swalloed, it is perfectly safe.
4. Clean off any remaining gel residue by brushing your teeth and gargling.
Stop Use
If there is any discomfort, please stop using.
Ask Doctor
If there is any discomfort, please consult a dentist immediately
Keep Oot Of Reach Of Children
keep out of reach of young children
Directions
1. Remove strips from backer.
2. Apply upper strip to top teeth, and repeat with bottom teeth.
3. Leave for 30 minutes, avoid eating or drinking.
4. Remove and discard strips, rinse away any existing gel and admire.
Other Information
please keep in dry and cool place
Inactive Ingredients
Glycerin、Water/Aqua、PVP、Ethylcellulose、Alcohol、Sodium Polyacrylate、Xylitol、Potassium Citrate、Hydroxyapatite、Rebaudioside A 、Menthol、Sodium Citrate、Xanthan Gum、PVM/MA Copolymer、C12-15Pareth-3
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