PEROXYL MOUTH SORE MILD MINT- hydrogen peroxide rinse

PEROXYL MOUTH SORE MILD MINT by

Drug Labeling and Warnings

PEROXYL MOUTH SORE MILD MINT by is a Otc medication manufactured, distributed, or labeled by Colgate Oral Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 10 mL)

Hydrogen peroxide 150 mg

Purpose

oral debriding agent

Use

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.

Warnings

• Do not use this product for more than 7 days unless directed by a dentist or physician.

• When using this product, do not swallow.

• 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

• Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

store at controlled room temperature 20-25° C (68-77° F)

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, FD&C blue no.1

Questions?

1-800-962-2345

PRINCIPAL DISPLAY PANEL - 50 Packet Carton

Colgate®

Peroxyl®

MOUTH SORE
RINSE
ALCOHOL-FREE
1.5% Hydrogen Peroxide

MILD MINT

50 Unit Dose Packets 0.34 FL OZ (10 mL) Each
TOTAL 17 FL OZ (1.06 PT) 502 mL

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)