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 Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 clanse canker sores
• assists in the removal of foreign material from minor oral wounds

Warnings

For this product

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

Disclaimer

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

Adverse Reactions

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA

with US and foreign parts

462.002/462AA

Principal display panel

mountain

falls

Compare to Colgate

alcohol

free

cleans and

helps relieve

minor mouth

and gum

irritation

helps reduce

bacteria to

promote better

oral health

hydrogen

peroxide

mouth rinse

oral debriding agent

mint

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: 0869-0462
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0462-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/02/2017

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0462)