FORMA-RAY- formaldehyde liquid

Forma-Ray by

Drug Labeling and Warnings

Forma-Ray by is a Prescription medication manufactured, distributed, or labeled by Gordon Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

A tinted aqueous perfumed base provides preferable vehicles for the topical application of formalin solution to relieve severe conditions of bromidrosis and hyperhydrosis. This formula is double the strength of Formadon. Formalin solution dries the skin's surface, and makes a very good drying agent after surgery or laser treatment.

HOW SUPPLIED

2 oz sponge tip plastic bottle and 4 oz plastic bottle.

SPL UNCLASSIFIED SECTION

Formaldehyde (20% of USP strength) formulated in a aqueous perfumed base.

INDICATIONS & USAGE

Indications: Antiperspirant for the treatment of hyperhydrosis and bromidrosis. Drying agent for verrucae. Drying agent for post surgical removal of warts or for nonsurgical laser treatment of warts. Directions: Apply to feet twice weekly or as prescribed by a Physician.

WARNINGS AND PRECAUTIONS

Contraindications/Warnings: Avoid frequent use. Avoid frequent use. Avoid contact with eyes or mucous membranes. Do not apply to open wounds. Should signs of irritation develop, medications should be discontinued. Irritates eyes. nose and throat. Keep out of reach of children. For external use only. Harmful if swallowed. Contact your local poison control center immediately. Do not induce vomiting. If conscious, give eight ounce of (240ml) of milk, or water with activated charcoal.

SPL UNCLASSIFIED SECTION

Keep well closed in a cool place.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORMA-RAY  
formaldehyde liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10481-3015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525)	FORMALDEHYDE	.2 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10481-3015-2	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/15/2010

Labeler - Gordon Laboratories (002333847)

Registrant - Gordon Laboratories (002333847)

Establishment
Name	Address	ID/FEI	Business Operations
Gordon Laboratories		002333847	manufacture