lidocaine HCl
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.