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 10%)
DRYING AGENT
RX ONLY

Drug Facts
Active Ingredient: Formaldehyde 10% Purpose: Drying agent
Uses:

    * Drying agent for pre and post surgical removal of warts.
    * For non-surgical laser removal of warts where dryness is required.
    * Safeguards against offensive odor and dries excessive moisture of feet.

Warnings: For external use only.
When using this product:

    * Avoid contact with skin 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 skin.
    * When not in use, keep cap closed tightly.

Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.
KEEP OUT OF REACH OF CHILDREN. HARMFUL IF SWALLOWED, CONTACT A LOCAL POSION CONTROL CENTER IMMEDIATELY. SAFETY AND EFFECTIVENESS IN PEDIATRIC PATIENTS HAVE NOT BEEN ESTABLISHED.
Directions:

    * Apply with the roll-on applicator once a day to affected areas or as directed by your PODIATRIST, DERMATOLOGIST OR PHYSICIAN.

Other Information:

    * Store at controlled room temperature 15 – 30 C (59 – 86 F).
    * See package insert for complete information.

Inactive ingredients
Water, polysorbate 20, hydroxyethyl cellulose, fragrance.

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

FORMALAZ
formaldehyde 10% 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	8.872 g in 88.72 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68032-194-03	88.72 mL In 1 BOTTLE, WITH APPLICATOR	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		09/16/2006

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Establishment
Name	Address	ID/FEI	Operations
A.I.G. Technologies, Inc.		171837367	manufacture

Revised: 10/2009River's Edge Pharmaceuticals, LLC