HYDROGEN PEROXIDE SOLUTION [LABORATORIOS JALOMA, S.A. DE C.V.]

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HYDROGEN PEROXIDE SOLUTION [LABORATORIOS JALOMA, S.A. DE C.V.]
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NDC 65055-501-01, 65055-501-02
Set ID 8477bb55-d479-494a-a5bc-c8408a763900
Category HUMAN OTC DRUG LABEL
Packager Laboratorios Jaloma, S.A. de C.V.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active Ingredient

    Hydrogen Peroxide 3%

  • Purpose

    Antiseptic

  • Uses

    first aid to help prevent infection in minor cuts scrapes • burns

  • Warnings

    For external use only•do not use in the eyes or apply over large areas of the body.

    Consult a doctor in case of • deep or puncture wounds • animal bites • serious burns.

    Stop use and consult a doctor if the condition persists or gets worse.

    Do not use longer than 1 week unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of accidental ingestion get medical help or contact a Poison Control Center right away.

  • Directions

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

  • Other information

    Store the bottle tightly closed and away from heat.

  • Inactive ingredients

    acetanilide, water

  • Questions

    (33) 3617 5010 (in Guadalajara, Jal., Mexico)

  • Jaloma Hydrogen Peroxide Topical Solution

    224mL Label448mL

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETANILIDE (UNII: SP86R356CC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-501-01224 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2013
    2NDC:65055-501-02448 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2013
    Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-501)
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