Formalaz

formaldehyde

Dosage Form: liquid
Formalaz

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 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 NDC Product Code (Source) 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%)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-194-03 85.05 g In 1 BOTTLE, WITH APPLICATOR None

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: 12/2010River's Edge Pharmaceuticals, LLC

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