Label: PERIO DAILY DEFENSE- hydrogen peroxide gel
- NDC Code(s): 59883-017-03
- Packager: Den-Mat Holdings, LLC
- 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 August 30, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children section
-
Directions
For children under 2 years of age, consult a dentist or physician.
For adults and children 2 years of age or older:
- Apply several drops of gel directly onto the affected area in the mouth.
- Leave the material on the affected area for at least 60 seconds, then spit.
- Use up to 4 times daily after meals and or at bedtime, or as directed by a dentist or physician.
- Other Information
- Inactive Ingredients
- Labeling
-
INGREDIENTS AND APPEARANCE
PERIO DAILY DEFENSE
hydrogen peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59883-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 17 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE (UNII: LAV5U5022Y) SORBITOL (UNII: 506T60A25R) POLYSORBATE 20 (UNII: 7T1F30V5YH) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLOXAMER 407 (UNII: TUF2IVW3M2) ALCOHOL (UNII: 3K9958V90M) PHOSPHORIC ACID (UNII: E4GA8884NN) Product Characteristics Color Score Shape Size Flavor MINT ((Clean Mint)) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-017-03 1 g in 1 TUBE; Type 0: Not a Combination Product 08/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/31/2022 Labeler - Den-Mat Holdings, LLC (809857704) Establishment Name Address ID/FEI Business Operations Dental Technologies, Inc. 148312838 manufacture(59883-017) , label(59883-017) , pack(59883-017)