LIDOCAINE HCI HYDROCORTISONE ACETATE  - lidocaine hydrochloride and hydrocortisone acetate cream 
Kylemore Pharmaceuticals, LLC

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Lidocaine HCI 3% - Hydrocortisone Acetate 0.5% Cream

DESCRIPTION:

Lidocaine is chemically designated as acetamide, 2-(diethylamino)- N-(2,6-dimethylphenyl), and has the following structure:

structure1

Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11ß)-. It has the following structural formula:

structure2

INGREDIENTS: Lidocaine HCI 3% - Hydrocortisone Acetate 0.5% Cream
Each 7g tube of Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% contains 30 mg of Lidocaine HCl and 5 mg of Hydrocortisone Acetate per gram. Inactive ingredients include: Purified Water, White Petrolatum USP, Stearic Acid NF, Cetyl Alcohol NF, Propylene Glycol USP, Stearyl Alcohol NF, Mineral Oil USP, Polysorbate 60, Sorbitan Monostearate, Methylparaben NF, Propylparaben NF, Sodium Hydroxide NF, Aluminum Sulfate and Calcium Acetate

CLINICAL PHARMACOLOGY:

MECHANISM OF ACTION:

PHARMACOKINETICS:


















INDICATIONS:

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

CONTRAINDICATIONS:


WARNINGS:

For external use only. Not for ophthalmic use.

Keep products, cleansing wipes and applicators out of the reach of children.


PRECAUTIONS:


CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:





USE IN PREGNANCY:

Teratogenic Effects:

NURSING MOTHERS:

PEDIATRIC USE:

ADVERSE REACTIONS:



Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:




HOW SUPPLIED:

Lidocaine HCI 3% - Hydrocortisone Acetate 0.5% Cream contains 14 1/4 oz. (7 g) Tubes and Applicators. NDC 49769-111-01.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 20º-25ºC (68º-77ºF). Protect from freezing.

Manufactured for:
Kylemore Pharmaceuticals
Suwanee, GA 30024
Rev. 12/09 111-10

PACKAGING:

Sample carton:

carton

Sample label:

label


LIDOCAINE HCI HYDROCORTISONE ACETATE 
lidocaine hydrochloride, hydrocortisone acetate   cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-111
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 30 mg  in 1 g
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 49769-111-01 98 g In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/12/2010

Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010 Kylemore Pharmaceuticals, LLC