ODORONO ANTIPERSPIRANT AND DEODORANT ROLL-ON POWDER (ALUMINUM CHLOROHYDRATE) LIQUID [OMEGA & DELTA CO]

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ODORONO ANTIPERSPIRANT AND DEODORANT ROLL-ON POWDER (ALUMINUM CHLOROHYDRATE) LIQUID [OMEGA & DELTA CO]
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NDC 51048-202-25
Set ID 38d4f89f-01c6-499c-8687-010a0dabc1c8
Category HUMAN OTC DRUG LABEL
Packager Omega & Delta Co
Generic Name
Product Class
Product Number
Application Number PART350
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  • SPL UNCLASSIFIED SECTION

    24 HORAS DE PROTECCIÓN    !Odorono, Sí Responde!
    USO: Reduce la humedad en las axilas. PRECAUCIONES: Solo para uso externo. No usar sobre piel irritada o lastimada. Detenga su uso si presenta irritación o alguna molestia. Mantengase fuera del alcance de los niños. Si se ingiere buscar ayuda médica. INSTRUCCIONES DE USO: Aplique unicamente en las axilas. INGREDIENTE ACTIVO: Clorohidrato de aluminio OTROS INGREDIENTES: Agua, PPG-15 estearil éter, Estearet-2, Estearet-21, Fragancia, EDTA disódico, BHT, Triclosán. IMPORTADO Y DISTRIBUIDO POR:El Salvador - Dizac S.A. de C.V., Registro No. 1EC94191208 Panamá - Medimex S.A., Registro No. 64611 Nicaragua - Contesa S.A., Registro No. México - Grupo Agroindustrial San Miguel, Candido Aviles #37 Col. Lomas de Memetla Distrito Federal, C.P. 05330 R.F.C. GAS960629976.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Aluminum Chlorohydrate 20%

  • Purpose

    Antiperspirant

  • INDICATIONS & USAGE

    Use: Reduces underarm wetness

  • WARNINGS

    Warnings: For external use only

  • DO NOT USE

    Do not use on broken skin

  • STOP USE

    Stop use if rash or irritation occurs

  • ASK DOCTOR

    Ask a doctor before use if you have kidney disease

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center.

  • DOSAGE & ADMINISTRATION

    Directions:  Apply evenly to underarms only

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Water, PPG-15 Stearyl Ether, Steareth-2, Steareth-21, Fragrance, Disodium EDTA, BHT, Triclosan

  • SPL UNCLASSIFIED SECTION

    Hecho en Puerto Rico por:

    Omega & Delta Co., Inc.

    P.O. Box 1831, Carolina, P.R. 00984

  • PRINCIPAL DISPLAY PANEL

    Odorono PowderOdorono Powder

  • INGREDIENTS AND APPEARANCE
    ODORONO  ANTIPERSPIRANT AND DEODORANT ROLL-ON POWDER
    aluminum chlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51048-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51048-202-2574 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/08/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35005/08/2006
    Labeler - Omega & Delta Co (090317793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omega & Delta Co090317793manufacture(51048-202)
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