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 H E B, 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

Questions?

Call 1-888-593-0593

SPL UNCLASSIFIED SECTION

*This product is not manufacted or distributed by Church & Dwight Co., Inc distributor of Orajel.

SEALED WITH PRINTED NACKBAND FOR YOUR PROTECTION

Made with pride and care for HEB San Antonio, TX 78204

DSP-TN-15000   DSP-MO-34   SDS-TN-15012

Principal display panel

Compare to Orajel*

HEB Oral Sore Antiseptic Rinse

ORAL PAIN RELIEVER & DEBRIDING AGEN WITH HYDROGEN PEROXIDE & MENTHOL

• Temporary pain relief for mouth sores
• For mouth sores, including gum irritation from braces or dentures & canker sores

16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

ORAL SORE ANTISEPTIC 
hydrogen peroxide, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-024
Route of Administration	ORAL

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
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: 37808-024-43	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 Drug	M022	03/15/2020

Labeler - H E B (007924756)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(37808-024)