Label: DOP HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid

  • NDC Code(s): 51048-040-08, 51048-040-16, 51048-040-32
  • Packager: Omega & Delta Co. Inc.
  • 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 December 2, 2015

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  • Drug Facts
  • Active Ingredient

    Hydrogen peroxide (stabilized) 3%   

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  • Purpose

    first aid antiseptic/Oral debriding agent

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  • INDICATIONS & USAGE

    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

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  • WARNINGS

    Warnings For external use only

    Do not use • in the eyes or apply over large areas of the body • do not use longer than 1 week

    Ask a doctor before use if you have deep or punctured wounds, animal bites 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 • irritation, pain or redness persists or worsens • swelling, rash or fever develops.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    First aid antiseptic:

    • clean the affected area
    • apply small amount of product on the affected area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged, 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 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.

    • 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
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  • OTHER SAFETY INFORMATION

    Other Information  Keep thightly closed and a controlled room temperature.  Do not

    shake bottle.  Hold away from face when opening.

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  • INACTIVE INGREDIENT

    Inactive Ingredient  Purified Water.

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Omega & Delta Co., Inc.

    Carolina, P.R. 00984

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  • INGREDIENTS AND APPEARANCE
    DOP HYDROGEN PEROXIDE 3% 
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51048-040
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51048-040-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2000
    2 NDC:51048-040-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2006
    3 NDC:51048-040-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2000
    Labeler - Omega & Delta Co. Inc. (090317793)
    Establishment
    Name Address ID/FEI Business Operations
    Omega & Delta Co. Inc. 090317793 manufacture(51048-040)
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