ANTISEPTIC MOUTH SORE- hydrogen peroxide, menthol rinse 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Pharmacy, Inc. Antiseptic Mouth Sore Rinse Drug Facts

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

antiseptic-mouth-sore-rinse
ANTISEPTIC MOUTH SORE 
hydrogen peroxide, menthol rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-515
Route of AdministrationPERIODONTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-515-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/18/2021
Labeler - CVS Pharmacy (062312574)

Revised: 1/2022
Document Id: 0a849f0b-2906-4859-bf06-b7562f54310d
Set id: 0a849f0b-2906-4859-bf06-b7562f54310d
Version: 1
Effective Time: 20220105
 
CVS Pharmacy