Active Ingredients
Lidocaine 4%
Menthol 1%
Lidocaine 4% Plus Menthol 1% Topical Anesthetic Pain Cream
FDA Label NDC 73715-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mohnark Pharmaceuticals Inc for the product Lidocaine 4% Plus Menthol 1% Topical Anesthetic Pain Cream (NDC 73715-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 area
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°C (68-77°F).
Inactive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin,
polysorbate 80, propylene glycol, tocopheryl acetate, trolamine,
water.
Usage
Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.
Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.
Dosage And Administration
Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.
Children under 2 years of age. Consult a doctor.
Package Label
Lidocaine 4% Plus Menthol 1% (Fda Panel)
* Please review the disclaimer below.
