Lidocaine Hydrochloride and Hydrocortisone Acetate

FDA Drug Profile — Lidocaine Hydrochloride and Hydrocortisone Acetate

Drug Details

Generic Name
Lidocaine Hydrochloride and Hydrocortisone Acetate
Brand Names
Lidocaine Hydrochloride and Hydrocortisone Acetate
Application Number
Sponsor
Seton Pharmaceuticals
NDC Codes
5
Dosage Forms
CREAM, GEL
Routes
RECTAL, TOPICAL
Active Ingredients
HYDROCORTISONE ACETATE, LIDOCAINE HYDROCHLORIDE

Indications and Usage

INDICATIONS: Product is used for the anti-inflammatory and anesthetic relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes.

Warnings

WARNINGS: For external use only. Not for ophthalmic use. Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear. Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.