Label: ANTISEPTIC MOUTH SORE- hydrogen peroxide, menthol rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 5, 2022

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  • 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
  • INGREDIENTS AND APPEARANCE
    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)
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