HYDROGEN PEROXIDE SOLUTION [PIONEER ASSOCIATES]

HYDROGEN PEROXIDE SOLUTION [PIONEER ASSOCIATES]
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NDC 53033-003-01, 53033-003-02, 53033-003-03, 53033-003-04, 53033-003-05, 53033-003-06, 53033-003-07, 53033-003-08, 53033-003-09, 53033-003-10, 53033-003-11
Set ID 3faa36a2-3d15-42a2-a03e-a76ef4e5d506
Category HUMAN OTC DRUG LABEL
Packager Pioneer Associates
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 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

    oral debriding agent (oral rinse):

    • 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 ingredient

    Water

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    CAVALIER HYDROGEN PEROXIDE SOLUTION

    FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

    16 FL.OZ (473 mL)

  • PRINCIPAL DISPLAY PANEL

    hydrogen-peroxide

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53033-003
    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:53033-003-08100 mL in 1 BOTTLE, PLASTIC
    2NDC:53033-003-01119 mL in 1 BOTTLE, PLASTIC
    3NDC:53033-003-02178 mL in 1 BOTTLE, PLASTIC
    4NDC:53033-003-09200 mL in 1 BOTTLE, PLASTIC
    5NDC:53033-003-03237 mL in 1 BOTTLE, PLASTIC
    6NDC:53033-003-10250 mL in 1 BOTTLE, PLASTIC
    7NDC:53033-003-11266 mL in 1 BOTTLE, PLASTIC
    8NDC:53033-003-04295 mL in 1 BOTTLE, PLASTIC
    9NDC:53033-003-05354 mL in 1 BOTTLE, PLASTIC
    10NDC:53033-003-06414 mL in 1 BOTTLE, PLASTIC
    11NDC:53033-003-07473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2012
    Labeler - Pioneer Associates (012604336)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(53033-003)

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