Label: SODIUM 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

    Sodium Hydroxide Solution 10%, Purified Water

  • HOW SUPPLIED

    Sodium Hydroxide Solution 10% is supplied in a 2 oz. amber glass bottle.

  • INDICATIONS & USAGE

    Used to destroy or kill the mail matrix (matrixectomies). Sodium Hydroxide 10% forms a strongly alkaline and caustic solution. As a caustic agent, it is used to destroy organic tissue by chemical action.

    Use two 10 second applications. NaOH must be neutralized with 5%

  • WARNINGS AND PRECAUTIONS

    Enter section text here

    For external use only. Harmful if taken internally. For Physician use only. 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. Contact a Physician. Keep out of reach of children.


  • SPL UNCLASSIFIED SECTION

    Federal law prohibits dispensing without prescription. Physician use only.

  • SPL UNCLASSIFIED SECTION

    Enter section text here

    Store at room temperature 59-86 F(15-30C)

  • PRINCIPAL DISPLAY PANEL

    Image of the Sodium Hydroxide label
  • INGREDIENTS AND APPEARANCE
    SODIUM HYDROXIDE 
    sodium hydroxide liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10481-3006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM HYDROXIDE.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10481-3006-159 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