DermacinRx Lidotral LIDOCAINE HYDROCHLORIDE PURETEK CORPORATION FDA Approved Lidotral™ (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Ingredients: Each gram of Lidotral™ 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic. image description

DERMACINRX LIDOTRAL

Generic: LIDOCAINE HYDROCHLORIDE
Mfr: PURETEK CORPORATION FDA Rx Only
FunFoxMeds box
Substance Lidocaine Hydrochloride
Route
TOPICAL
Product NDC
59088-0371-00 59088-0371-07
Package NDC
59088-371-07

Drug Facts

Composition & Profile

Strengths
3.88 % 85 g
Treats Conditions
Indications For The Temporary Relief Of Pain And Itching Associated With Minor Burns Sunburn Minor Cuts Scrapes Insect Bites And Minor Skin Irritation

Identifiers & Packaging

Container Type BOX
NDC 59088-0371-00
All Product Codes
59088-0371-00 59088-0371-07
UNII
V13007Z41A
SPL Set IDs
23efec58-67cc-418d-85f5-7ef156443cbf
Packaging

HOW SUPPLIED DermacinRx ® Lidotral™ (Lidocaine HCl) 3.88% Cream 3 oz (85 g) tube - NDC 59088-371-07; PRINCIPAL DISPLAY DermacinRx ® Lidotral™ (Lidocaine HCl) 3.88% Cream - 3 oz (85 g) carton image description

Package Descriptions
  • HOW SUPPLIED DermacinRx ® Lidotral™ (Lidocaine HCl) 3.88% Cream 3 oz (85 g) tube - NDC 59088-371-07
  • PRINCIPAL DISPLAY DermacinRx ® Lidotral™ (Lidocaine HCl) 3.88% Cream - 3 oz (85 g) carton image description
Overview

Lidotral™ (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Ingredients: Each gram of Lidotral™ 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic. image description

Indications & Usage

INDICATIONS For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

Dosage & Administration

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

Warnings & Precautions
WARNINGS For external use only. Not for ophthalmic use.
Contraindications

Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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.

Storage & Handling

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured by: PureTek Corporation, San Fernando, CA 91340 Rev. 37744 10/15 image description

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Additional Information

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