ORAL SORE ANTISEPTIC- hydrogen peroxide, menthol liquid

Oral Sore Antiseptic by

Drug Labeling and Warnings

Oral Sore Antiseptic by is a Otc medication manufactured, distributed, or labeled by Old East Main CO., Vi-Jon, LLC, VI-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredients

Hydrogen peroxide 1.5% (w/v)

Menthol 0.1% (w/v)

purpose

Oral debriding agent/Oral antiseptic
Oral pain reliever

uses

▪ first aid to help protect against bacterial contamination in minor oral wounds
▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪  dentures ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouthUses
▪ first aid to help protect against bacterial contamination in minor oral wounds
▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or minor gum inflammation resulting from: ▪ minor dental procedures ▪  dentures
▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth and gums ▪ canker sores
▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with occasional sore mouth

warnings

Stop use and ask a doctor if
▪ sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
▪ irritation, pain, or redness persists or worsens
▪ swelling, rash, or fever develops
▪ sore mouth symptoms do not improve in 7 days

When using this product

•  do not swallow 
•  do not use more than 7 days unless directed by a dentist or doctor 
•  do not exceed recommended dosage

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 - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily 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 doctor

other information

• store at controlled room temperature 68-77°F (20-25°C) 
•  keep away from heat or direct sunlight

inactive ingredients

alcohol (4.1% v/v), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

SAFETY SEAL

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888)309-9030

princpal display panel

Since 1903

Rexall

Oral Sore

Antiseptic

Rinse

• For mouth sores, including gum irritation from braces or dentures and canker sores
• Kills germs and bacteria

MINT

FLAVOR

473 mL (16 FL OZ)

INGREDIENTS AND APPEARANCE

ORAL SORE ANTISEPTIC 
hydrogen peroxide, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-785
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.5 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-785-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/15/2020

Labeler - Old East Main CO. (068331990)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
VI-Jon, Inc		790752542	manufacture(55910-785)