WHITE MERTODOL (BENZALKONIUM CHLORIDE) SPRAY [LABORATORIOS JALOMA, S.A. DE C.V.]

WHITE MERTODOL (BENZALKONIUM CHLORIDE) SPRAY [LABORATORIOS JALOMA, S.A. DE C.V.]
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NDC 65055-302-02
Set ID 8e3f62c2-298b-4d82-b72c-a9b785add322
Category HUMAN OTC DRUG LABEL
Packager Laboratorios Jaloma, S.A. de C.V.
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    First aid to help prevent infection in *minor cuts *scrapes *burns

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use in the eyes or apply over large areas of
    the body
    Do not use longer than 1 week, unless directed by a
    doctor

  • ASK DOCTOR

    Consult a doctor in case of * deep puncture
    wounds * animal bites * serious burns

  • STOP USE

    Stop use and consult a doctor if the condition

    persists or gets worse

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.  In case of

    accidental ingestion, seek professional assistance

    or contact a Poison Control Center immediately.

  • 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

  • Inactive Ingredients

    acetone, alcohol, water

  • QUESTIONS

    Questions

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

  • White Mertodol

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  • INGREDIENTS AND APPEARANCE
    WHITE MERTODOL  
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-302-0240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/21/2016
    Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-302)

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