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]

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Drug Facts

Active ingredient

Hydrogen peroxide 1.5% (w/v)

Purposes

Oral debriding agent/oral wound cleanser

Uses

• for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums

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 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

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

Other Information

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

Questions?

1-800-468-6502

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Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE*

Colgate®
Oral Debriding Agent

Peroxyl®

Mouth Sore Rinse |
1.5% Hydrogen
Peroxide

CLEANSES & PROMOTES HEALING
OF MINOR ORAL WOUNDS

HELPS PROMOTE HEALING OF:

• ✓ ORAL SORES
• ✓ IRRITATIONS
• ✓ MOUTH BURNS

MILD MINT

16.9 FL OZ
(1.05 PT)
500 mL

Helps Promote Healing

P9933376

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)
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

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. (968801118)