Label: ODORONO ANTIPERSPIRANT AND DEODORANT ROLL-ON POWDER- aluminum chlorohydrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 12, 2020

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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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