HYDROGEN PEROXIDE LIQUID [HOME SMART PRODUCTS]

HYDROGEN PEROXIDE LIQUID [HOME SMART PRODUCTS]
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NDC 52862-007-02, 52862-007-03, 52862-007-04, 52862-007-05, 52862-007-06, 52862-007-07, 52862-007-08, 52862-007-09, 52862-007-10, 52862-007-11, 52862-007-12
Set ID 5c8f7727-5f21-4a69-8af1-c24b43571d4d
Category HUMAN OTC DRUG LABEL
Packager Home Smart Products
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active ingredient (by volume)

    Hydrogen Peroxide 3%

  • PURPOSE

    Purpose

    first aid antiseptic/oral debriding agent

  • 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
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than one week
    • on deep or puncture wounds, animal bites or on serious burns
  • ASK DOCTOR

    Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • swelling, rash or fever develops
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children.

    If swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    first aid antiseptic:

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

    oral debriding agent:

    • adults and children 2 years of age and over:
    • mix with 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
  • SPL UNCLASSIFIED SECTION

    Other information

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

    Inactive ingredients

    Water

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART HYDROGEN PEROXIDE LIQUID
    FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

    16 FL.OZ (473 mL)

  • PRINCIPAL DISPLAY PANEL

    hydrogen-peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-007
    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:52862-007-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    2NDC:52862-007-03119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    3NDC:52862-007-04178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    4NDC:52862-007-05200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    5NDC:52862-007-06237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    6NDC:52862-007-07250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    7NDC:52862-007-08266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    8NDC:52862-007-09295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    9NDC:52862-007-10354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    10NDC:52862-007-11414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    11NDC:52862-007-12473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2012
    Labeler - Home Smart Products (161872676)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-007)

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