Label: LUCKY SUPER SOFT HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

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 December 16, 2022

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First aid antiseptic

    Oral debriding agent

  • Uses

    ■ first aid to help prevent the risk of infection in minor cuts, scrapes, and burns ■ aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

  • Warnings

    For external use only (as a first aid antiseptic).

    Do not use

    in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

    Stop use and consult a doctor if

    the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

    As oral debriding agent:

    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 swelling, rash, or fever develops, see your dentist or doctor promptly

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    for use as a first aid antiseptic: Clean the affected area. Apply a small amount of this product on affected area 1to 3 times a daily.

    May be covered with a sterile bandage. If bandaged, let dry first

    For use as an oral debriding agent:

    Adults and children 2 years of age and older: Mix with an equal amount of warm water. Swish around in the mouth over 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

    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

    keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening

  • Inactive ingredients

    purified water

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPER SOFT HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-300-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/02/2021
    Labeler - Delta Brands Inc (102672008)