Label: PRO BRIGHTEN TOOTH WHITENING GEL- hydrogen peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70810-001-01, 70810-001-02 - Packager: Sangleaf Pharm., Co Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 6, 2016
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRO BRIGHTEN TOOTH WHITENING GEL
hydrogen peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70810-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrogen Peroxide (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) Hydrogen Peroxide 3 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70810-001-02 1 in 1 CARTON 07/06/2016 1 NDC:70810-001-01 100 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/06/2016 Labeler - Sangleaf Pharm., Co Ltd (689847343) Registrant - Sangleaf Pharm., Co Ltd (689847343) Establishment Name Address ID/FEI Business Operations Sangleaf Pharm., Co Ltd 689847343 manufacture(70810-001)
