lidocaine HCl

FDA Drug Profile — REGENECARE HA

Drug Details

Generic Name
lidocaine HCl
Brand Names
REGENECARE HA
Application Number
M017
Sponsor
MPM Medical LLC
NDC Codes
2
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
LIDOCAINE HYDROCHLORIDE

Indications and Usage

INDICATIONS: Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

Warnings

PRECAUTIONS: For external use only. Not for ophthalmic use. Product and used applicators could harm small children if chewed or swallowed. Keep out of reach of children. 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 contraindicted because of ototoxicty 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.