FDA Label for Lidocaine 4% Topical Anesthetic Cream
View Indications, Usage & Precautions
Lidocaine 4% Topical Anesthetic Cream Product Label
The following document was submitted to the FDA by the labeler of this product Mohnark 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 Ingredients
Lidocaine 4% w/w
Purpose
Topical Anesthetic
Uses temporarily relieves pain and itching due to:
- minor cuts
- minor scrapes
- sunburn
- minor skin irritations
- minor burns
- insect bites
Warnings
For external use only
When Using This Product
- do not use in or near the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- redness, irritation, swelling, pain or other symptoms begin or increase
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 and older: apply externally to the affected area up to 3-4 times a day.
- Children under 2 years of age: consult a doctor
Other Information
- Store at USP controlled room temperature 20-25 oC (68-77 oF).
Inactive Ingredients
benzyl alcohol, cabomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water
Dosage
40 milligrams/gram per application
Usage
- Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
- Children under 2 years of age: consult a doctor
Package Label
* Please review the disclaimer below.