ANTISEPTIC ORAL CLEANSER- hydrogern peroxide mouthwash

Antiseptic Oral Cleanser by

Drug Labeling and Warnings

Antiseptic Oral Cleanser by is a Otc medication manufactured, distributed, or labeled by OLD EAST MAIN CO., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 10 mL)

Hydrogen Peroxide 150mg

Purpose

Oral debriding agent/Oral wound cleanser

Use

oral debriding agent/oral wound cleanser 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 such as mouth burns, cheek bites and toothbrush abrasions

WARNINGS

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 in 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

rinse half a capful (two teaspoons or 10 mL mark on cap) around in 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

Other information

store at controlled room temperature  20-25⁰ C (68-77⁰F)

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1

SPL UNCLASSIFIED SECTION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DISRRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% SATISFACTION GUARANTEED (888)- 309-9030

princpal display panel

Rexall
Antiseptic Oral Cleanser Hydrogen Peroxide
Promotes healing of oral irritations
Oral debriding agent
Great tasting original flavor
8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

ANTISEPTIC ORAL CLEANSER 
hydrogern peroxide mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-171
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	150 mg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-171-34	.236 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/19/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/19/2009

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55910-171)