Data from FDA - Curated by EPG Health - Last updated 25 January 2018

Indication(s)

INDICATIONS: 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.

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Advisory information

contraindications
CONTRAINDICATIONS: 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.
Special warnings and precautions
PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. CidalEaze (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.
Adverse reactions
ADVERSE REACTIONS: 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Apply a thin film to the affected area two or three times daily or as directed by a physician.
Pregnancy and lactation
NURSING MOTHERS: 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.

More information

Category Value
Agency product number V13007Z41A
Orphan designation No
Product NDC 15455-9526
Date Last Revised 10-01-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1010835
List of excipients ACTIVE INGREDIENTS: Each gram of CidalEaze (Lidocaine 3% Cream) contains lidocaine hydrochloride 3% (30 mg). INACTIVE INGREDIENTS: aluminum sulfate, calcium acetate, cetyl alcohol, glycerine, glyceryl monostearate SE, methyl paraben, mineral oil, propyl paraben, purified water, sodium hydroxide, sorbitan stearate, stearic acid, stearyl alcohol, and white petrolatum.
Storage and handling STORAGE AND HANDLING Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F), however, such exposure should be minimized. [See USP Controlled Room Temperature]. Protect from Freezing. Keep tightly closed. See bottom of bottle and outside of carton for lot number and expiration date. Manufactured for: Alvix Laboratories, LLC 6601 Sunplex Drive Ocean Springs, MS 39564 1-888-526-5449 Logo
Marketing authorisation holder Alvix Laboratories, LLC