FDA Label for Lidocaine Pain Relief
View Indications, Usage & Precautions
Lidocaine Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, 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(S)
Lidocaine 4%
Purpose
Topical anesthetic
Uses
Temporary relief of pain
Do Not Use
- more than one patch at a time
- on wounds or damaged, broken or irritated skin
- if you are allergic to any ingredients of this product
When Using This Product
- use only as directed • read and follow all directions and warnings
- do not allow contact with eyes and mucous membranes
- do not bandage tightly • do not apply local heat such as a heating pad
- do not use other topical anesthetics at the same time
Stop Use And Ask A Doctor If
- localized skin reactions occur, such as rash, itching, redness, irritation,
pain, swelling and blistering - conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a healthcare 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 over 12 years:
- clean and dry affected area
- remove film from patch and apply to the skin
- apply one patch to affected area not more than 3 to 4 times a day
- remove patch from the skin after at most 12-hour application
Children under 12 years of age: consult a doctor
Inactive Ingredients
dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl
alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, urea, water
Comments Or Questions:
1-800-845-8210
††This product is not manufactured or distributed by Chattem, Inc., distributor of Aspercreme® Lidocaine Patch.
Distributed By
MADE IN JAPAN
C09750050222 R02/22
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