Label: PEROXYL MOUTH SORE MILD MINT- hydrogen peroxide rinse
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NDC Code(s):
0126-0083-16,
0126-0083-22,
0126-0083-31,
0126-0083-70, view more0126-0083-99
- Packager: Colgate Oral Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 25, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purposes
- Uses
- Warnings
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Directions
- Adults and children 2 years of age and older: rinse half a capful (two teaspoons or 10 mL) around in the mouth over affected area for at least 1 minute, then spit out
- Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
- Children under 12 years of age should be supervised in the use of the product
- Children under 2 years of age: consult a dentist or physician
- Inactive ingredients
- Other Information
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 50 Dose Packet Carton
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INGREDIENTS AND APPEARANCE
PEROXYL MOUTH SORE MILD MINT
hydrogen peroxide rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0126-0083 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 338 (UNII: F75JV2T505) POLYSORBATE 20 (UNII: 7T1F30V5YH) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE (Light Blue Solution with the Smell of Mint) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0126-0083-16 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2009 2 NDC:0126-0083-99 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2015 3 NDC:0126-0083-70 50 in 1 CARTON 03/15/2017 3 10 mL in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0126-0083-31 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 11/25/2024 5 NDC:0126-0083-22 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M022 01/01/2009 Labeler - Colgate Oral Pharmaceuticals Inc. (968801118) Registrant - COLGATE PALMOLIVE COMPANY (001344381)