Label: SORE MOUTH CLEANSER- hydrogen peroxide mouthwash

  • NDC Code(s): 69842-008-34, 69842-008-77
  • Packager: CVS Pharmacy, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 6, 2024

If you are a consumer or patient please visit this version.

  • Active ngredient

    Hydrogen peroxide 150 mg/10mL

  • Purpose

    Oral debriding agent/Oral wound cleanser

  • Uses

    • aids in the removal of phlgem, mucus, or other secretions associated with occasional sore mouth
    • for temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, acidental injury, or other irritations of the mouth and gums
    • for temporary use to cleanse canker sores
    • assists in the removal of foreign material from minor oral wounds
  • Warnings

    For this product

  • 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 redenss persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly

  • When using this product

    do not swallow

  • 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: rinse two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
    • children under 12 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)

  • inactive ingredients

    water, sorbitol, propylene glcol, poloxamer 338, polysorbate 20, flavor, sodium saccharin, blue 1

  • Disclaimer

    This product is not manufactured or distributed by Colgate Oral Pharmaceuticals, distributor of Colgate Peroxyl Mouth Sore Rinse Alcohol-Free Mild Mint

  • Adverse Reactions

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2015 CVS/Pharmacy

    CVS.com  1-800-shop CVS

    Made in the U.S.A. with U.S. and Foreign Parts

    CVS Quality

    Money Back Guarantee

    Please Recycle

    462.002/462AA rev 1

  • Principal display panel

    CVS

    Health

    Compare to the active ingredient in Colgate Peroxyl Oral Cleanser*

    Alcohol Free

    Peroxide Sore

    Mouth Cleanser

    HYDROGEN PEROXIDE 1.5%

    • Oral debriding agent
    • Oral antiseptic
    • Helps reduce bacteria to promote better oral health

    Soothing Mint

    Sealed with printed neckband for your protection. Do not use if broken or missing.

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SORE MOUTH CLEANSER 
    hydrogen peroxide mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE150 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-008-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2012
    2NDC:69842-008-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02202/03/2012
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(69842-008)