Label: PEROXYL MOUTH SORE MILD MINT- hydrogen peroxide rinse
- NDC Code(s): 0126-0083-70
- Packager: Colgate Oral Pharmaceuticals, Inc.
- 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.
Updated September 8, 2015
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 10 mL)
oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inf ammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions.
- Do not use this product for more than 7 days unless directed by a dentist or physician.
- Stop use and ask a doctor if
- sore mouth symptoms do not improve within 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- adults and children 2 years of age and older: rinse contents of this package (two teaspoons) 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 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
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 50 Packet Carton
INGREDIENTS AND APPEARANCE
PEROXYL MOUTH SORE MILD MINT
hydrogen peroxide rinse
Product 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Polysorbate 20 (UNII: 7T1F30V5YH) Saccharin Sodium (UNII: SB8ZUX40TY) Product Characteristics Color BLUE (Light Blue Solution with the Smell of Mint) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0126-0083-70 50 in 1 CARTON 1 10 mL in 1 POUCH; 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 01/01/2009 Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)