Drug Details [pdf]

FORMALDEHYDE- formaldehyde solution
Rochester Pharmaceuticals

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.

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Formaldehyde 10%

Rx Only

For Topical Use Only

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 treatment of warts where dryness is required. Safeguards against offensive odor and dries excessive moisture of 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 THE REACH OF CHILDREN. Safety and effectiveness in pediatric patients have not been 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.

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

Available in a 3 oz (88.71mL) roll-on plastic bottle - NDC: 49908-167-90.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C-30°C (between 59°F abd 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); howeverm such exposure should be minimized.

Manufactured for:

Rochester Pharmaceuticals

Doylestown, PA 18901

1-866-458-1772

www.RochesterPharm.com

September 2015

PACKAGE LABEL

image of label

FORMALDEHYDE
formaldehyde solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49908-167
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525)	FORMALDEHYDE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49908-167-90	88.71 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/27/2011	07/08/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/27/2011	07/08/2019

Labeler - Rochester Pharmaceuticals (134473771)

Revised: 7/2019

Document Id: 8d30784e-4c01-84c4-e053-2a95a90ae0a9

Set id: 06ab03b5-07ed-4087-9f04-7a4ea2743169

Version: 21

Effective Time: 20190708

Drug Labeling and Warnings

Drug Details [pdf]

PACKAGE LABEL