Label: STEFANO GLADIUS ROLL-ON- 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 June 2, 2015

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Aluminum Chlorohydrate

  • PURPOSE

    Purpose:

    Antiperspirant

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    USE:

    Reduces underarm persperation

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • INDICATIONS & USAGE

    DIRECTIONS

    APPLY UNDER ARM ONLY

    SHAKE WELL BEFORE USE

  • WARNINGS AND PRECAUTIONS

    DO NOT APPLY ON IRRITATED OR INJURED SKIN. DISCONTINUE USE IF YOU EXPERIENCE SOME IRRITATION, REDNESS OR DISCOMFORT

  • INACTIVE INGREDIENT

    WATER, SOYOIL, STEARTH-2, PPG-15 STEARYL ETHER, STEARETH-20, FRAGANCE, CAPRYLY GLYCOL. TETRASOSIUM EDTA, AND BHT

  • PRINCIPAL DISPLAY PANEL

    IngredientsStefano Roll-in

  • INGREDIENTS AND APPEARANCE
    STEFANO GLADIUS  ROLL-ON
    aluminum chlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    ISOSTEARETH-20 (UNII: 78H2SJ8X8M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-040-0150 mL in 1 APPLICATOR; Type 0: Not a Combination Product06/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35006/02/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA Genesis078760958relabel(69772-040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate Palmolive S.A. de C.V.810007526manufacture(69772-040)
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