FORMALDEHYDE

Rochester Pharmaceuticals

FULL PRESCRIBING INFORMATION: CONTENTS*

• PACKAGE LABEL

FULL PRESCRIBING INFORMATION

Formaldehyde 10%

Rx Only

For Topical Use Only

ACTIVE INGREDIENTS:  formaldehyde 10% 

INACTIVE INGREDIENTS: water, polysorbate 20, hydroxyethyl cellulose, fragrance.

Uses

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

Rochester, NY 14624

1-866-458-1772

www.RochesterPharm.com

June 2013 

PACKAGE LABEL