Drug Catalog - Product Detail
LIDOCAINE/HYDROCORTISONE CREAM KIT KIT 3%/0.5% 20CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13925-0165-20 | SETON PHARMACEUTICALS | 1 | 3-0.5% | KIT |
PACKAGE FILES
Generic Name
LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE
Substance Name
HYDROCORTISONE ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
RECTAL
Application Number
Description
DESCRIPTION: Lidocaine 3% - Hydrocortisone 0.5% Cream Kit are indicated 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.
How Supplied
HOW SUPPLIED: Lidocaine 3% - Hydrocortisone 0.5% Cream Kit 20 Count Kit, NDC 13925-165-20 Containing: 20 single use ¼ oz (7g) Tubes (NDC 13925-165-07) of Lidocaine 3% -Hydrocortisone 0.5% Cream (a white cream), 20 Applicators and 20 Moist Wipes. Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). See USP Controlled Room Temperature. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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 and 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 use in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician. Patient Directions for Rectal Administration: Remove moist wipe from box, tear open the package, gently clean the affected area and discard moist wipe. (Note: The moist wipe does not contain any of the prescribed active ingredients.) The cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened. (Do not over tighten.) While holding the tube, gently squeeze the tube until a small amount of cream/gel comes out of the applicator openings. This will lubricate the applicator tip. Gently insert the applicator tip into anal area. Continue squeezing the body of the tube as you move it around the areas of discomfort, and lastly, around and in the anal opening (if directed by physician). Do not completely insert the applicator and tube into the anus or insert deep into the rectum. Do not insert a loose applicator tip into the anus or rectum. Once application is completed, the tube and applicator tip should be gently removed and discarded.