Lidocaine Hydrochloride and Hydrocortisone Acetate 25 mg/g
Lidocaine Hydrochloride and Hydrocortisone Acetate · GEL · Seton Pharmaceuticals
Lidocaine Hydrochloride and Hydrocortisone Acetate is a gel containing lidocaine hydrochloride and hydrocortisone acetate at 25 mg/g, taken rectal. Manufactured by Seton Pharmaceuticals.
Key Facts
- Brand Name
- Lidocaine Hydrochloride and Hydrocortisone Acetate
- Generic Name
- Lidocaine Hydrochloride and Hydrocortisone Acetate
- NDC Code (Product)
13925-164- Manufacturer
- Seton Pharmaceuticals
- Strength
- 25 mg/g
- Dosage Form
- GEL
- Route
- RECTAL
- Marketing Status
- Marketing Start
- 06/17/2011
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply product to the affected area(s) twice daily or as directed by a physician. Product should not be used in excess of recommendations or for prolonged used in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advise of your physician. Products without applicators Remove the child-resistant cap and foil seal from the tube. Apply a thin film to the affected area. Replace the cap after use.
Warnings
WARNINGS For external use only. Not for ophthalmic use. Product 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.
Contraindications
CONTRAINDICATIONS Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with "caine" ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any components of the preparation.
Adverse Reactions
ADVERSE REACTIONS During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
Frequently Asked Questions
What is Lidocaine Hydrochloride and Hydrocortisone Acetate used for?
Lidocaine Hydrochloride and Hydrocortisone Acetate contains Lidocaine Hydrochloride and Hydrocortisone Acetate. It is a gel taken rectal. Consult your doctor for specific uses.
Is Lidocaine Hydrochloride and Hydrocortisone Acetate a controlled substance?
Lidocaine Hydrochloride and Hydrocortisone Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Lidocaine Hydrochloride and Hydrocortisone Acetate?
The generic name for Lidocaine Hydrochloride and Hydrocortisone Acetate is Lidocaine Hydrochloride and Hydrocortisone Acetate. There are no other listed brand versions of Lidocaine Hydrochloride and Hydrocortisone Acetate.
What is the NDC code for Lidocaine Hydrochloride and Hydrocortisone Acetate 25 mg/g?
The NDC (National Drug Code) for Lidocaine Hydrochloride and Hydrocortisone Acetate 25 mg/g is 13925-164, listed by Seton Pharmaceuticals.
Other Lidocaine Hydrochloride and Hydrocortisone Acetate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)