Label: ASSURED- aluminum sulfate powder

  • 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 April 25, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Aluminum sulfate  56%

  • PURPOSE

    Purpose

    Astringent

  • INDICATIONS & USAGE

    Uses  stops bleeding caused by minor surface cuts and abrasions as may

    occur during shaving

  • WARNINGS

    Warnings

    For external use only.

    When using this product, avoid contact with eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a

    Poison Control Centerright away.

  • DOSAGE & ADMINISTRATION

    Directions

    • moisten tip of pencil with water and apply to affected area.
    • dry pencil after use.
  • INACTIVE INGREDIENT

    Inactive ingredients   titanium dioxide

  • DESCRIPTION

    Styptic Pencil

    • Helps Stop Bleeding Quickly
    • Great for Use on Nicks and Minor Cuts from Shaving
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    aluminum sulfate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0828
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SULFATE (UNII: 34S289N54E) (ALUMINUM SULFATE ANHYDROUS - UNII:I7T908772F) ALUMINUM SULFATE56 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0828-128 g in 1 BLISTER PACK; Type 0: Not a Combination Product04/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/20/2016
    Labeler - Greenbrier International (610322518)
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