Label: LIDOCAINE HYDROCHLORIDE, HYDROCORTISONE ACETATE gel

  • NDC Code(s): 24470-964-01, 24470-964-20
  • Packager: Cintex Services, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 17, 2024

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  • Rx Only DESCRIPTION:
    This product 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 ...
  • CLINICAL PHARMACOLOGY:
    Mechanism of Action: Product releases lidocaine to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local ...
  • 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 ...
  • 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 ...
  • WARNINGS: KEEP OUT OF REACH OF CHILDREN.
    Product, applicators and moist wipes could harm small children if chewed or swallowed. Methemoglobinemia - Cases of methemoglobinemia have been reported in association with local anesthetic use ...
  • PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
    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 ...
  • ADVERSE REACTIONS:
    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 ...
  • 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 ...
  • STORAGE:
    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic ...
  • HOW SUPPLIED:
    Each carton, NDC 24470-964-20, contains 20 single-use ¼ oz (7 g) tubes of Lidocaine 3% - Hydrocortisone 2.5% Gel, 20 applicators, and 20 moist wipes. Each tube is a unit of use - not for ...
  • PRINCIPAL DISPLAY PANEL
    carton
  • INGREDIENTS AND APPEARANCE
    Product Information