Label: 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 October 22, 2020

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  • Drug Facts

  • Active ingredient

    Hydrogen peroxide 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.

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

    Ask a doctor before use if you have • deep puncture 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

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

  • DOSAGE & ADMINISTRATION

    Directions For use a 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

    For use as an 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 at least 1 minute and then spit out. Do not swallow.

    • use up to 4 times 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 doctor or dentist

  • Other information

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

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    Topical Solution USP 3%

    First Aid Antiseptic/Oral Debriding Agent

    For Treatment of Minor Cuts & Abrasions

    For Use As a Gargle or Rinse

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

    Distributed by:

    Universal Distribution Center

    96 Distribution Boulevard

    Edison, NJ 08817

    Made in India

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-025
    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:52000-025-40100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    2NDC:52000-025-41119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    3NDC:52000-025-42178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    4NDC:52000-025-43200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    5NDC:52000-025-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    6NDC:52000-025-44250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    7NDC:52000-025-45266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    8NDC:52000-025-31295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    9NDC:52000-025-32354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    10NDC:52000-025-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    11NDC:52000-025-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/25/2015
    Labeler - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOTEK INDIA675484458manufacture(52000-025)
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