Label: DAWNMIST UNSCENTED ROLL-ON ANTIPERSPIRANT DEODORANT- aluminum chlorohydrate solution

  • 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 July 17, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient

    Aluminum Chlorohydrate 7.8%


  • PURPOSE

    Purpose

    Antiperspirant

  • INDICATIONS & USAGE

    Use: Reduces underarm perspiration

  • WARNINGS

    Warnings


    For external use only.
    Do not use on broken skin.
    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a 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 and contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Apply to underarms only.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Mineral Oil, Polysorbate 60, Glycerin, Peg-100 Stearate, Sorbitan Monostearate, Ceteraryl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Glyceryl Monostearate, Hydroxyethylcellulose, Sodium Benzoate, Methylparaben, Disodium EDTA, Propylparaben

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Donovan Industries, Inc.

    Tampa, Florida 33626-3061

    800.334.4404

    www.DawnMist.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    DawnMist

    Fights Wetness and Odor

    Unscented

    Roll-On

    Antiperspirant

    Deodorant

    2 FL. OZ 59ml

  • PRINCIPAL DISPLAY PANEL

    DS2

  • INGREDIENTS AND APPEARANCE
    DAWNMIST UNSCENTED ROLL-ON ANTIPERSPIRANT DEODORANT  
    aluminum chlorohydrate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-9002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE78 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55504-9002-159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35010/01/2010
    Labeler - Donovan Industries, Inc. (096662267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Haishi Biological Technology Co., Ltd. 421262738manufacture(55504-9002)
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