Label: POTASSIUM HYDROXIDE- potassium hydroxide liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 16, 2010

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  • DESCRIPTION

    Clear liquid solution containing Potassium Hydroxide Solution 5%.

  • HOW SUPPLIED

    Potassium Hydroxide Solution 5% supplied as 2oz. Amber Glass Bottle.

  • SPL UNCLASSIFIED SECTION


    Potassium Hydroxide Solution 5%, Purified water (usp)
  • INDICATIONS & USAGE

    Used as a softener for nail grooves. Also used as a slide medium in Potassium Hydroxide preparations. Apply to nail in office.

  • WARNINGS AND PRECAUTIONS

    May cause skin irritation. Do not get in eyes, on skin, or on clothing. In case of contact, immediately flush skin or eyes with plenty of water for at least 15 minutes. For eyes, contact a Physician. For external use only. Keep out of reach of children. For Physician use only. Poison: Harmful if taken internally.

  • SPL UNCLASSIFIED SECTION

    For Physician use only. Store at room temperature 59o-86oF (15o - 30o C)

  • PRINCIPAL DISPLAY PANEL

    Image of Potassium Hydroxide Solution

  • INGREDIENTS AND APPEARANCE
    POTASSIUM HYDROXIDE  
    potassium hydroxide liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10481-3012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) (POTASSIUM HYDROXIDE - UNII:WZH3C48M4T) POTASSIUM HYDROXIDE.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10481-3012-159 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/16/2010
    Labeler - Gordon Laboratories (002333847)
    Registrant - Gordon Laboratories (002333847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gordon Laboratories002333847manufacture