ROLL ON ANTI PERSPIRANT ALCOHOL FREE (ALUMINUM CHLOROHYDRATE) SOLUTION [HYDROX LABORATORIES]

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ROLL ON ANTI PERSPIRANT ALCOHOL FREE (ALUMINUM CHLOROHYDRATE) SOLUTION [HYDROX LABORATORIES]
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NDC 10565-066-02
Set ID c5fb6769-23a3-4738-afe7-5ebbca4d9e69
Category HUMAN OTC DRUG LABEL
Packager Hydrox Laboratories
Generic Name
Product Class
Product Number
Application Number PART350
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Aluminum Chlorohydrate, 10% - Anhydrous Basis

  • Purpose

    Antiperspirant

  • Use

    Reduces underarm wetness.

  • Warnings

    FOR EXTERNAL USE ONLY.

    KEEP OUT OF REACH OF CHILDREN.

    Do not use on broken skin.

    Stop use if rash or irritation occurs.

    Ask a doctor before use if you have kidney disease.

    If swallowed, get medical help or contact a Poison Control Center immediately. Use only as directed.

  • Directions

    Apply to underarms. Use daily for best results.

  • Inactive ingredients

    Purified Water, Hydroxyethylcellulose, Glycerin, Polysorbate 20, Fragrance, Tetrasodium EDTA

  • PRINCIPAL DISPLAY PANEL 

    Personal Care

    FreshMoment

    Anti-Perspirant
    Deodorant Roll-On
    Alcohol-Free

    Helps Reduce Wetness
    Spring Fresh Fragrance

    MADE IN USA

    1.5 FL. OZ. (45mL)

    Principal Display Panel - 45 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    ROLL ON ANTI PERSPIRANT  ALCOHOL FREE
    aluminum chlorohydrate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10565-066-0245 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/26/2011
    2NDC:10565-066-0145 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/26/201110/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35010/26/2011
    Labeler - Hydrox Laboratories (025164302)
    Registrant - Hydrox Laboratories (025164302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302MANUFACTURE(10565-066) , label(10565-066) , pack(10565-066)
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