SORE MOUTH CLEANSER- hydrogen peroxide mouthwash

Sore Mouth Cleanser by

Drug Labeling and Warnings

Sore Mouth Cleanser by is a Otc medication manufactured, distributed, or labeled by Walgreens, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hydrogen peroxide 150 mg/10mL

Purpose

Oral debriding agent/Oral wound cleanser

Uses

• aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
• for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
• for temporary use to cleanse canker sores
• assists in the removal of foreign material from minor oral wounds

WARNINGS

Warnings

Do not use

this product for more than 7 days unless directed by a dentist or doctor.  If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

When using this product

do not swallow

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 two teaspoons (10 mL) around the mouth 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 pysicial
• children under 12 should be supervised in the use of the product
• children under 2 years of age: consult a dentist or doctor

Other information

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

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, methyl salicylate, menthol, sodium saccharin, blue 1

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse 

DIST.BY: WALGREEN CO.,

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com 2013 Walgreen Co.

MADE IN THE U.S.A. WITH U.S. AND FOREIGN COMPONENTS

462.001/462AA

principal display panel

Well at Walgreens

PEROXIDE

Mouth Rinse

Hydrogen Peroxide/Oral Debriding Agent

Helps reduce bacteria to promote better oral health
Oral wound cleanser
Mint

Compare to Colgate Peroxyl Mouth Sore Rinse active ingredient

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

SORE MOUTH CLEANSER 
hydrogen peroxide mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1588 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)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0085-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/02/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/02/2014

Labeler - Walgreens (008965063)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0363-0085)