FDA Label for Lidocaine Hcl 4% Menthol 1%
View Indications, Usage & Precautions
Lidocaine Hcl 4% Menthol 1% Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. 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.
Otc - Active Ingredient
Lidocaine HCl 4%
Menthol 1%
Inactive Ingredient
benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E
Dosage & Administration
Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.
BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.
Children under 12 years: ask a doctor
Indications & Usage
temporary relieves minor pain
Warnings
For external use only
Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.
When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.
Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Topical anesthetic
Topical analgesic
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