Label: UTRASURE- otc antiprespirant drug product spray

  • Category: HUMAN OTC DRUG LABEL

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 17, 2020

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  • Active Ingredient

    Aluminum Sesquichlorohydrate 15%

  • Purpose:

    Anti-perspirant

  • Uses:

    • Reduce underarm wetness
    • 24 hour protection
  • Warnings:

    • For external use only.
    • Do not use on broken skin.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask doctor if you have Kidney Disease.

  • Warnings:

    • Keep out of reach of children. If swallowed, contact physician or Poison Control Center right away.
  • Directions:

    • Apply to under arms only.
    • Hold in an upright position about 6 inches from the underarm and spray.
  • Other Information

    • Store at room temperature (59°-86°F).
    • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047
  • Inactive Ingredients:

    Fragrance, PEG-40 Castor Oil, Propylene Glycol, SD Alcohol 40-B, Water

  • Questions?

    Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

  • Package Label Principal Display Panel

    UltraSure

  • INGREDIENTS AND APPEARANCE
    UTRASURE 
    otc antiprespirant drug product spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-266
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE0.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-266-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/24/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35002/24/2010
    Labeler - DermaRite Industries LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaRite Industries LLC883925562api manufacture(61924-266)
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