Label: SALICYLIC ACID - salicylic acid liquid 

  • Label RSS
  • NDC Code(s): 49908-137-10
  • Packager: Rochester Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/13

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Rn Only

    Salicylic Acid, 26%

    FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC. ORAL OR INTRAVAGINAL USE.

    Salicylic Acid, 26% is a topical preparation for treatment of common and plantar warts, in a film-forming vehicle composed of acrylates copolymer, isopropyl alcohol, isobutyrate, n-butyl acetate, and polyvinyl butyrate.  The pharmacologic activity of this medication is generally attributed to the
    keratolytic activity of salicylic acid which is incorporated into a film-forming vehicle designed to cover the wart without the need for a bandage. The chemical structural formula of salicylic acid is:


    image of chemical


    Close
  • CLINICAL PHARMACOLOGY

    Although the exact mode of action of salicylic acid in the treatment of warts is not known, its activity appears to be associated with its keratolytic action which results in mechanical removal of epidermal cells infected with wart viruses.

    Close
  • INDICATIONS & USAGE

    Salicylic Acid, 26% is indicated for the topical treatment and removal of common warts and plantar warts.

    Close
  • CONTRAINDICATIONS

    Salicylic Acid, 26% should not be used by diabetics or patients with impaired blood circulation. Salicylic Acid, 26% should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.

    Close
  • PRECAUTIONS

    Salicylic Acid, 26% is for external use only. Do not permit Salicylic Acid, 26% to contact eyes or mucous membranes.  If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Salicylic Acid, 26% should not be allowed to contact normal skin surrounding the wart. Treatment should be discontinued if excessive irritation occurs. Salicylic Acid, 26% is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use.

    Close
  • ADVERSE REACTIONS

    A localized irritant reaction may occur if Salicylic Acid, 26% is applied to the normal skin surrounding the wart.  Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.

    Close
  • DOSAGE & ADMINISTRATION

    Prior to application of Salicylic Acid, 26%, soak wart in warm water for five minutes.  Remove any loosened tissue by gently rubbing with a brush, wash cloth or emery board. Dry thoroughly. Using the brush applicator supplied, apply twice to entire wart surface, allowing the first application to dry before applying the second. Treatment should be once or twice a day and should continue as directed by physician. Be careful not to apply to surrounding skin.  Clinically visible improvement will normally occur during the first or second week of therapy.  Maximum resolution may be expected after four to six weeks of drug use.

    Close
  • HOW SUPPLIED

    Salicylic Acid, 26% is supplied in 10 mL amber bottles with a brush applicator - NDC 49908-137-10

    Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Manufactured for:
    Rochester Pharmaceuticals
    Rochester, NY 14624
    1-866-458-1772
    www.RochesterPharm.com

    SA26-PI-0213

    Close
  • PACKAGE LABEL

    image of label

     

     

    Image of Label

     

     

     

     

     

    image of carton

     

     

    Image of Carton

     

     

    Close
  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    salicylic acid liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49908-137
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 260 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL  
    BUTYL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49908-137-10 1 in 1 CARTON
    1 10 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/30/2011
    Labeler - Rochester Pharmaceuticals (069874500)
    Close