Label: DIVAS - hydrogen peroxide liquid

  • NDC Code(s): 51444-004-73
  • Packager: JMD All Star Impex Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 8, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Hydrogen peroxide 3%

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  • PURPOSE

    Purpose
    First aid antiseptic/oral debriding agent
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  • INDICATIONS & USAGE

    Uses
    first aid to help prevent risk of infection in minor cuts ,scrapes and burns
    • aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth Close
  • WARNINGS

    Warnings
    For external use only

    Do not use
     
    • in the eyes or apply over large areas of the body  • more than one week Close
  • ASK DOCTOR

    Consult a doctor before use if you have
    animal bites or serious burns, deep or punctured wounds Close
  • STOP USE

    Stop use and consult a doctor if  
    • the condition persists or gets worse
    • sore mouth symptoms do not improve in a week
    • pain redness or irritation persists or if you develop fever ,rash or swelling Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately Close
  • DOSAGE & ADMINISTRATION

    Directions
    First aid antiseptic                                                                                                 oral debriding agent (oral rinse)
    •clean affected area                                                                                               Adults and children 2 years and over
    •apply a small amount of this product on the affected area 1-3 times a day                 • mix with an equal amount of water
    • may be covered with a sterile bandage                                                                   • swish around in the mouth over affected area for at least 1 minute then spit out
                                                                                                                                 • use up to 4  times daily after meals and at
                                                                                                                                   bedtime or as suggested by a doctor or dentist
    •let dry first before using bandage

    for children under 2 years: consult a dentist or a doctor
    children under 12 years should be supervised in the use of this product
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  • SPL UNCLASSIFIED SECTION

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

    Inactive ingredients
    purified water Close
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label


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  • INGREDIENTS AND APPEARANCE
    DIVAS 
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51444-004
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51444-004-73 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333 07/26/2010
    Labeler - JMD All Star Impex Inc (962316662)
    Establishment
    Name Address ID/FEI Business Operations
    Steller Mercantile Pvt.Ltd. 650493005 manufacture
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