Label: PERIORESTORE- hydrogen peroxide gel
- NDC Code(s): 59883-018-87
- Packager: DEN-MAT HOLDINGS, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Indications & Uses
- Warnings
- Keep out of reach of children.
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Directions
For children under 2 years of age, consult dentist or physician.
For adults and children 2 years of age and older:
1. Apply several drops of gel directly onto the affected area in the mouth.
2. Leave the material on the affected area for at least 60 seconds, then spit.
3. Use up to 4 times daily after meals and or a bedtime, or as directed by a dentist or physician.
- Other Information
- Inactive Ingredients
- Principal Display Panel
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PERIORESTORE
hydrogen peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59883-018 Route of Administration DENTAL 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 SORBITOL (UNII: 506T60A25R) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) PHOSPHORIC ACID (UNII: E4GA8884NN) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLOXAMER 407 (UNII: TUF2IVW3M2) ALCOHOL (UNII: 3K9958V90M) 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:59883-018-87 1 in 1 BOX 07/15/2019 1 85 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 Drug M022 07/15/2019 Labeler - DEN-MAT HOLDINGS, LLC. (809857704)