Formalaz

Generic Name: formaldehyde
Dosage Form: 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.

Formalaz

ACTIVE INGREDIENTS:

Formaldehyde 10%

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INACTIVE INGREDIENTS:

Water, Polysorbate 20, Hydroxyethyl Cellulose, Fragrance.

INDICATIONS:

Drying agent for pre and post surgical removal of warts, or for non-surgical laser removal of warts where dryness is required.

Safeguards against offensive odor and dries excessive moisture of the 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 REACH OF CHILDREN. Safety and effectiveness in pediatric patients have not be 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.

HOW SUPPLIED:

Available in 3 oz (85.05 gm) roll on plastic bottle.

Store at controlled room temperature 15 - 30 C (56 - 86 F).


RX ONLY.

Manufactured for:
RIVER'S EDGE PHARMACEUTICALS, LLC
Suwanee, GA 30024

REV 09/06

PRODUCT LABEL:

Formalaz 
formaldehyde liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-194
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FORMALDEHYDE (FORMALDEHYDE) FORMALDEHYDE 100 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
POLYSORBATE 20  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
Packaging
# Item Code Package Description
1 NDC:68032-194-03 85.05 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/16/2006 10/31/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Establishment
Name Address ID/FEI Operations
A.I.G. Technologies, Inc. 171837367 manufacture
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC



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