SALICYLIC ACID - salicylic acid liquid 
Rochester Pharmaceuticals

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.

----------

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


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.

INDICATIONS & USAGE

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

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.

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.

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.

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.

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

PACKAGE LABEL

image of label

 

 

Image of Label

 

 

 

 

 

image of carton

 

 

Image of Carton

 

 

SALICYLIC ACID 
salicylic acid liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:49908-137
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid260 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
BUTYL ACETATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49908-137-101 in 1 CARTON
110 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/2011
Labeler - Rochester Pharmaceuticals (069874500)

Revised: 3/2013
Document Id: 8feb4318-48d2-45c7-a9cb-833676de38d5
Set id: 1ef8ddd2-7f43-4e7f-b1da-ca694d975296
Version: 4
Effective Time: 20130325
 
Rochester Pharmaceuticals