Label: ANTIPERSPIRANT DRY 1.6 OZ MEN ANTIPERSPIRANT- aluminum chlorohydrate aerosol, spray

  • 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 January 13, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient ........................................................................... Purpose

    Aluminum Chlorohydrate 23.3% .................................................. Antiperspirant

  • PURPOSE

    Antiperspirant

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Reduces underarm wetness

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Do not use while smoking or near heat or flame or while smoking. Can cause serious injury or death.

    • Keep away from face and mouth to avoid breathing in.
    • Avoid spraying in eyes. CONTENTS UNDER PRESSURE. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120 oF/50 oC or in enclosed places that could overheat.
    • Do not use on broken skin.
    • Ask a doctor before using, if you have kidney disease
    • When using this product.
    • Keep away from face and mouth to avoid breathing it
    • avoid spraying in eyes
    • USE ONLY AS DIRECTED. INTENTIONAL MISSUSE BY DELIBERATELY CONCENTRATING AND INHAILING THE CONTENTS CAN BE HARMFUL OR FATAL.
    • Stop use if rash or irritation occurs

  • DOSAGE & ADMINISTRATION

    Directions

    • For underarm use only. Shake can well before each use. Hold can 6 inches away from skin. Spray underarm and spray
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Isobutane, Butane, Hydrofluorocarbon 152a, Cyclopentasiloxane, Alcohol, PPG-14 Butyl Ether, Helianthus Annuus Seed Oil, Isopropryl Myristate, C12-15 Alkyl Benzoate, Frangrance, Propane, Aluminum Starch Ocetenylsuccinate, Disteardimonium Hectorite, Dimethicone, Tocopheryl Acetate, BHT, Bentonite, Lauryl Phosphate

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ANTIPERSPIRANT DRY 1.6 OZ MEN  ANTIPERSPIRANT
    aluminum chlorohydrate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE23.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTANE (UNII: 6LV4FOR43R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANE (UNII: T75W9911L6)  
    BENTONITE (UNII: A3N5ZCN45C)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-105-0145 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35001/13/2020
    Labeler - Rejoice International Inc (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanit & Sons Company Limited660220096manufacture(57337-105)