HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [SMART SENSE (KMART)]

HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [SMART SENSE (KMART)]
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NDC 49738-268-16, 49738-268-32
Set ID ce31f6e2-888e-441d-8488-9c966afa7c38
Category HUMAN OTC DRUG LABEL
Packager SMART SENSE (Kmart)
Generic Name
Product Class
Product Number
Application Number PART356
  • 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 or 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.

  • Directions

    • For use as 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 bandaged, 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 dentist or doctor
  • Other information

    • Keep tightly closed and in a dark place at room temperature.
    • do not shake bottles. Hold away from face when opening.
  • Inactive ingredient

    purified water

  • Princiapl Display Panel

    Hydrogen Peroxide

    3% TOPICAL SOLUTION USP

    FIRST AID ANTISEPTIC

    TOPICAL ANTI-INFECTIVE FOR MINOR CUTS & ABRASIONS

    ORAL DEBRIDING AGENT GARGLE OR RINSE

    Distributed by: Kmart Corporation

    Hoffman Estates , IL 60179

    Shop kmart.com

    call 1-800-842-7886

    FL OZ (mL)

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

  • Package Label

    Hydrogen peroxide 3%

    smart sense hydrogen peroxide 3%

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201512/31/2021
    2NDC:49738-268-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/201512/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/31/201512/31/2021
    Labeler - SMART SENSE (Kmart) (008965873)

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