HYDROGEN PEROXIDE LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]

HYDROGEN PEROXIDE LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-025-03, 52000-025-06, 52000-025-07, 52000-025-31, 52000-025-32, 52000-025-40, 52000-025-41, 52000-025-42, 52000-025-43, 52000-025-44, 52000-025-45
Set ID 091bea0c-7582-45d7-b04e-7d49d7fc4648
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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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