Lidocaine 3% – Hydrocortisone 0.5% Cream

DESCRIPTION:

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lidocaine 3% – Hydrocortisone 0.5% Cream is 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.

INDICATIONS:

id: 0e412fad-448c-4086-b28f-f7842ac1eeb0
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Product is used for the anti-inflammatory and anesthetic 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: dbbceece-5616-4402-95fa-9b8c1dd14a76
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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 on patients receiving antiarrhythmic
drugs of Class I since the adverse effects are additive and generally
synergistic. This product is contraindicated for tuberculous or
fungal lesions or skin vaccinia, varicella and acute herpes simplex.
Topical corticosteroids are contraindicated in those patients with a
history of hypersensitivity to any of the components of the
preparation.

WARNINGS:

id: 72f5205e-d419-44aa-a94c-e107675a8858
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

For external use only. Not for ophthalmic use. 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 contraindicated because of ototoxicity 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.

PRECAUTIONS:

id: 9d9ff305-e113-49ea-8b2e-921e28b69824
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

If irritation or sensitivity occurs or infection
appears, discontinue use and institute appropriate therapy. If
extensive areas are treated, the possibility of systemic absorption
exists. Systemic absorption of topical steroids has produced
reversible hypothalamic pituitary-adrenal (HPA) axis suppression,
manifestations of Cushing’s syndrome, hyperglycemia, and
glycosuria in some patients. Conditions which augment systemic
absorption include the application of the more potent steroids, use
over large surface areas, prolonged use, and the addition of
occlusive dressings. Therefore, patients receiving a large dose of
potent topical steroids applied to a large surface area, or under an
occlusive dressing, should be evaluated periodically for evidence of
HPA axis suppression. If noted, an attempt should be made to
withdraw the drug to reduce the frequency of application, or to
substitute a less potent steroid. Recovery of the HPA axis function is generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid
withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionately larger amounts of topical
cortico-steroids and thus be more susceptible to systemic toxicity. If
irritation develops, topical steroids should be discontinued and
appropriate therapy instituted. In the presence of dermatological
infections, the use of an appropriate antifungal or antibacterial agent
should be instituted. If a favorable response does not occur promptly, the
corticosteroid should be discontinued until the infection has been
adequately controlled.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:

id: a9ffe890-6b81-4ac2-b2ff-6fec451b8fc6
displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6

Long-term animal studies have not been performed to evaluate the
carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone
have revealed negative results. Studies of lidocaine in animals to evaluate
the carcinogenic and mutagenic potential of the effect on fertility have not
been conducted.

NURSING MOTHERS:

id: 474390ec-2dd9-4142-9058-d913f37516d4
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: d5f703ea-3db2-4549-ad4d-4ebf39f27ef6
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Safety and efficacy in children have not been established.

ADVERSE REACTIONS:

id: ae9e013a-b247-4ad8-adc1-689e10c5a639
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

During, immediately, or 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.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS.

id: 788db0b7-6197-4e9f-80c0-196c3f28f95c
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

id: bb196fd5-ac45-4a75-9cd5-e2a9f009566c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply product to the affected area(s) twice daily or as directed by a
physician. If the condition does not respond to repeated courses of
product or should worsen, discontinue use and seek the advice of the
physician.

HOW SUPPLIED:

id: 6d911768-68f6-4271-a080-ee16c6fd7c3c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lidocaine 3% – Hydrocortisone 0.5% Cream is supplied as a white cream in:
1 oz (28.35 g) tubes NDC 13925-160-01
3 oz (85 g) tubes NDC 13925-160-03 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-77°F). See USP Controlled Room Temperature. Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

id: 3ad65d19-8ea8-4af6-9c1d-c1c8b99b0a0d
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. Manufactured for:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401 Iss. 5/11

Rx Only Seton Pharmaceuticals

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

id: 809c0eb2-41fc-4aca-a182-c6066afe6428
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only         NDC-13925-160-03        Net Wt. 3 oz. (85 g) Lidocaine 3%
Hydrocortisone 0.5% Cream Anti-Inflammatory Anesthetic FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. SETON PHARMACEUTICALS