Formaldehyde Liquid

Dosage Form: topical liquid

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.

Formaldehyde 10%

Rx Only

For Topical Use Only

ACTIVE INGREDIENTS:  formaldehyde 10% 

INACTIVE INGREDIENTS: water, polysorbate 20, hydroxyethyl cellulose, fragrance.

INDICATIONS:  Drying agent for pre and post surgical removal of warts, or for non-surgical laser treatment of warts where dryness is required.  Safeguards against offensive odor and dries excessive moisture of feet.  Not to be used in patients known to be sensitive to any of the ingredients in this product.

PRECAUTIONS:  FOR EXTERNAL USE ONLY:  HARMFUL IF SWALLOWED, CONTACT A LOCAL POISON CONTROL CENTER IMMEDIATELY.  KEEP OUT OF THE REACH OF CHILDREN.  Safety and effectiveness in pediatric patients have not been established.  Avoid contact and keep away from face, eyes, nose and mucous membranes.  Check skin for sensitivity to formaldehyde prior to application since it may be irritating and sensitizing to the skin of some patients.  If redness or irritation persists, consult your PODIATRIST, DERMATOLOGIST or PHYSICIAN.

DIRECTIONS:  Apply with the roll-on applicator once a day to affected areas, or as directed by your PODIATRIST, DERMATOLOGIST, or PHYSICIAN.  Do not shake the bottle with the cap removed.  When not in use, keep cap closed tightly.

Available in a 3 oz (88.71mL) roll-on plastic bottle - NDC 49908-167-90. 

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C-30°C (between 59°F abd 86°F).  Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); howeverm such exposure should be minimized.

Manufactured for:

Rochester Pharmaceuticals

Rochester, NY 14624

1-866-458-1772

www.RochesterPharm.com

June 2013 

PACKAGE LABEL

FORMALDEHYDE 
Formaldehyde Liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49908-167
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FORMALDEHYDE (Formaldehyde) FORMALDEHYDE 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Polysorbate 20  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
Packaging
# Item Code Package Description
1 NDC:49908-167-90 88.71 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/27/2011
Labeler - Rochester Pharmaceuticals (069874500)
Revised: 07/2013
 
Rochester Pharmaceuticals



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