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 Pharmacure 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.
Active Ingredient
Lidocaine 4%
Purpose
Topical Anesthetic
Uses
Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises
Warnings
Do not use on the face or rashes, on wounds or damaged skin, in the eyes, mouth, or other mucous membranes, on genitals, with a heating pad, any patch from a pouch that has been opened for 7 or more days.
Ask a doctor before use ifyou are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.
When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.
If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
For external use only
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.
Directions
Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.
Other Information
Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).
Inactive Ingredients
aluminium glycinate, edetate disodium, ethylhexylglycerin, glycerin, kaolin, phenoxyethanol, polyvinlprrolidone, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, water
Product Label
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