FDA Label for Lidocaine
View Indications, Usage & Precautions
Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Marlex Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 4%
Purpose
Pain & Itch Relief
Use
for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
Warnings
For external use only. Avoid contact with eyes. Not for prolonged use.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occurs again within a few days
- rash or irritation develops, persists, or increases
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
Directions
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor
Other Information
- May be applied under occlusive dressing
- store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Inactive Ingredients
Benzyl alcohol, carbopol 940, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate
Principal Display Panel - 15G Tube Carton
Lidocaine 4% Topical Anesthetic Cream
Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)
Principal Display Panel - 30G Tube Carton
Lidocaine 4% Topical Anesthetic Cream
Pain & Itch Relief Cream NET WT. (30g)
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