ANTISEPTIC MOUTH SORE- hydrogen peroxide, menthol rinse

Antiseptic Mouth Sore by

Drug Labeling and Warnings

Antiseptic Mouth Sore by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrogen peroxide 1.5%

Menthol 0.1%

Purpose

Oral debriding agent/Oral wound cleansing

Oral pain reliever

Uses

• For temporary use in cleansing minor wounds or gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, canker sores, or other irritations of the mouth and gums.
• For temporary relief of pain associated with canker sores

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 redness persists or worsens; or if swelling, rash, or fever develops, stop use and see your dentist or doctor promptly.

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 and older

• Swish one-half capful (2 teaspoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. Do not swallow.
• Children under 12 years of age should be supervised in the use of this product.

Children under 2 years of age: Consult a dentist or doctor.

Other Information

• Do not use if printed safety seal is broken or missing
• Recommended storage temperature 59°-77°F (15°-25°C)

Inactive Ingredients

Purified Water, Sorbitol, Poloxamer 407, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate, Sodium Saccharin, Xylitol, Citric Acid

Package/Label Principal Display Panel

ALCOHOL FREE

CVS Health®

Compare to the active ingredients in Orajel® Antiseptic Rinse

Antiseptic Mouth Sore Rinse

ORAL DEBRIDING AGENT / ORAL WOUND CLEANSER

- Dye Free

- Promotes healing & cleans oral wounds

- Relieves pain from canker sores, cheek bites, gum irritation & dental work

Fresh Mint

16 FL OZ (473 mL)

LFA4317F1

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH SORE 
hydrogen peroxide, menthol rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-515
Route of Administration	PERIODONTAL

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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XYLITOL (UNII: VCQ006KQ1E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-515-43	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/18/2021

Labeler - CVS Pharmacy (062312574)