Lidocaine 3% Cream

DESCRIPTION:

id: 507f497a-6033-455a-8927-05e2cba7b740
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lidocaine 3% Cream is a topical
anesthetic indicated for the relief of pruritus, pruritic
eczemas, abrasions, minor burns, insect bites, pain,
soreness, and discomfort due to pruritus ani, pruritus
vulvae, hemorrhoids, anal fissures, and similar conditions
of the skin and mucous membranes.

INDICATIONS:

id: 5ac88ed3-e5bb-4d84-a98d-38e8fca7219b
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Anesthetic for relief of pruritus, pruritic
eczemas, abrasions, minor burns, insect bites, pain,
soreness and discomfort due to pruritus ani, pruritus
vulvae, hemorrhoids, anal fissures, and similar conditions
of the skin and mucous membranes.

CONTRAINDICATIONS:

id: defb12f1-be5c-4c82-81e2-ab7faa384462
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Traumatized mucosa, secondary bacterial infection of the
area of proposed application and known hypersensitivity
to any of the components. Lidocaine is contraindicated in
patients with a known history of hypersensitivity to local
anesthetics of the amide type.

WARNINGS:

id: b0dcdb8d-a181-47e1-9bd8-1d48a3f9fe00
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

For external use only. Not for ophthalmic use.

PRECAUTIONS:

id: 1d7c6d92-676e-46eb-b43b-35116f3114be
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

If irritation or sensitivity occurs or
infection appears, discontinue use and institute
appropriate therapy. Lidocaine 3% Cream should be used
with caution in ill, elderly, debilitated patients and
children who may be more sensitive to the systemic
effects of lidocaine.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:

id: 5fa59001-bf86-47f5-94ba-c2ab1c8ac364
displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6

Studies of lidocaine in animals to evaluate the
carcinogenic and mutagenic potential of the effect on
fertility have not been conducted.

NURSING MOTHERS:

id: 679a0b8f-c495-4bee-98e9-7d29f1892c56
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2

Lidocaine is excreted in human milk. The clinical
significance of this observation is unknown. Caution
should be exercised when lidocaine is administered to a
nursing woman.

PEDIATRIC USE:

id: bd1bda71-bfcb-414a-8ef3-e8d059f94fbe
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0

Dosage in pediatric patients should be reduced commensurate with age, body weight and physical condition.

ADVERSE REACTIONS:

id: 9b4b307a-2e5c-4967-9212-759855b8ad29
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

During or immediately after treatment, the skin at the site
of treatment may develop erythema or edema or may be
the locus of abnormal sensation.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS.

id: 97c21641-cb35-4507-b013-35b5e7ff4347
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

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

DOSAGE AND ADMINISTRATION:

id: 75ebfc06-cc21-4b2a-85d6-5d9a751d0c0e
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply a thin film to the affected area two or three times daily or as directed by a physician.

HOW SUPPLIED:

id: 969fa2c6-3e0b-4643-939d-ade13f2c4933
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lidocaine 3% Cream is supplied as a white cream in:
1 oz. (28.35 g) tubes, NDC 13925-159-01
3 oz. (85 g) tubes, NDC 13925-159-03.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

id: b435f831-38de-4e16-8640-9cd4649d3474
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

All prescriptions using this product shall be pursuant to
state statutes as applicable. This is not an Orange Book
product. This product may be administered only under a
physician’s supervision. There are no implied or explicit
claims on the therapeutic equivalence. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC
(59º-86º F). See USP Controlled Room Temperature.
Protect from freezing. Manufactured for:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401 Iss. 5/11

Rx Only Seton Pharmaceuticals

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

id: 699628a4-c737-4050-9145-45bfe709327e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only         NDC-13925-159-01        Net Wt. 1 oz. (28.35 g) Lidocaine 3% Cream
Topical Anesthetic FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. SETON PHARMACEUTICALS