Formaldehyde Liquid

Formaldehyde 10%

Rx Only

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.

Formaldehyde Liquid 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 is Formaldehyde Liquid 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.

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