Lidozen

LIDOCAINE, MENTHOL TOPICAL HUMAN OTC DRUG

Lidozen is an FDA drug label for the active ingredient LIDOCAINE, MENTHOL manufactured by Proficient Rx LP administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231201.

Generic name
LIDOCAINE, MENTHOL
Manufacturer
Proficient Rx LP
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
71205-348
Application
M017
Label effective
20231201

Active ingredients

ACTIVE INGREDIENTS: Lidocaine 4.00% Menthol 1.00% Topical Anesthetic External Analgesic

Indications & Usage

USES: For temporary relief of pain

Dosage & Administration

DIRECTIONS (Adults and Children Over 12 Years): Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches / day. Leave patch on affected area for up to 8 hours Do not use patches for longer than five consecutive days, Children under 12 should consult physician prior to use.

Contraindications

Not available.

Warnings

WARNINGS: • For external use only. • Avoid contact with eyes. • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Do not use • in large quantities, particularly over raw surfaces or blistered areas. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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