INGREDIENTS

Active: Formaldehyde 10% Inactives: Purified Water, Polysorbate 20, Hydroxyethyl Cellulose, Methanol, Menta Piperita (Peppermint) Oil.

INDICATIONS

Drying agent for pre and post surgical removal of warts or where dryness is required. Safeguards against offensive odor and dries excessive moisture of feet.

CONTRAINDICATIONS

Not to be used in patients known to be sensitive to any ingredients in Formaldehyde 10% Solution. Check skin for sensitivity to formaldehyde prior to application.

PRECAUTIONS

FOR EXTERNAL USE ONLY. HARMFUL IF SWALLOWED. CONTACT A LOCAL POISON CONTROL CENTER IMMEDIATELY. KEEP OUT OF THE REACH OF CHILDREN. Avoid contact with 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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Formaldehyde 10% is available in a 3 oz. (85.05 gm) plastic bottle with roll-on applicator. NDC 51991-512-19.

Dispense in original container.

Store at 25° C (77° F ); excursions permitted to 15° - 30°C (59° - 86° F). See USP Controlled Room Temperature. Protect from freezing.

Rx Only

Warning

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by:
Harmony Labs, Inc.
Kannapolis, NC 28083

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rev. 9/09

PRINCIPAL DISPLAY PANEL

Breckenridge
Pharmaceutical, Inc.

NDC 51991-512-19

Formaldehyde
10%

Drying Agent

Rx Only

3 oz. (85.05 gm)

FORMALDEHYDE
formaldehyde liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	51991-512
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Formaldehyde (Formaldehyde)	Formaldehyde	8.505 g in 88.72059 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Polysorbate 20
Methyl Alcohol
Peppermint Oil

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	51991-512-19	1 BOTTLE In 1 CARTON	contains a BOTTLE, WITH APPLICATOR
1		88.72059 mL In 1 BOTTLE, WITH APPLICATOR	This package is contained within the CARTON (51991-512-19)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved other		01/01/2009

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Harmony		784625760	MANUFACTURE

Revised: 10/2009Breckenridge Pharmaceutical, Inc.