Label: COMFORT- hydrogen peroxide liquid

  • NDC Code(s): 50827-650-16
  • Packager: Weimei Lianyungang Household Articles manufacturing, Co. LTD
  • 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 May 24, 2012

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

  • Active Ingredient

    Hydrogen Peroxide ( Stablized) 3%

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  • Package Label

    Hydrogen Peroxide

    Hydrogen Peroxide

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  • Purpose

    First Aid Antiseptics/Oral Debriding Agent

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  • 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 secrections assocated with occasional sore mouth

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  • Warnings

    For External Use only

    Do not use: in the eyes or apply over large areas of the body longer than a week

    Ask a doctor bbefore use if you have deep or punture wounds, animal bits or serious burns

    Stop use and ask a doctor if the condition persists or gets worse. Sore mouth symptoms do not improve in 7 days.

    Irriation, pain or redness persists or worsens. swelling, rash, or fever develops. Keep reach out of children. If swallowed, get medical help or contact a poison control center immediately.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep reach out of children. If swallowed, get medical help or contact a poison control center immediately.

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  • Directions

    first aid antiseptic:

    clean affected area
    apply small amount of product on affected area 1-3 times a day
    may be covered with a sterile bandage
    if bandage, let dry first


    oral debriding agent (oral rinse):


    adults and children 2 years of age and over
    mix with an equal amount of water
    swish around in the mouth over affected area for atleast 1 minute and spit out
    use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor.


    children under 12 years should be supervised in the use of this product
    children under 2 years of age; consult a dentist or doctor

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  • DOSAGE & ADMINISTRATION

    first aid antiseptic:

    clean affected area
    apply small amount of product on affected area 1-3 times a day
    may be covered with a sterile bandage
    if bandage, let dry first


    oral debriding agent (oral rinse):


    adults and children 2 years of age and over
    mix with an equal amount of water
    swish around in the mouth over affected area for atleast 1 minute and spit out
    use up to 4x daily after meals and at bedtime or as directed by a dentist or doctor.


    children under 12 years should be supervised in the use of this product
    children under 2 years of age; consult a dentist or doctor

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  • Other Information

    Keep tightly closed and in a dark place at a controlled room temperature. Do not shake bottle. Hold away from face when opening.

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  • Inactive Ingredient

    Purified water

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  • INGREDIENTS AND APPEARANCE
    COMFORT 
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50827-650
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50827-650-16 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 06/01/2012
    Labeler - Weimei Lianyungang Household Articles manufacturing, Co. LTD (546100731)
    Registrant - Weimei Lianyungang Household Articles manufacturing, Co. LTD (546100731)
    Establishment
    Name Address ID/FEI Business Operations
    Weimei Lianyungang Household Articles manufacturing, Co. LTD 546100731 manufacture(50827-650)
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