Active Ingredient
Lidocaine 4%
Lidocaine 4% Patch
FDA Label NDC 87236-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Lidocaine 4% Patch (NDC 87236-024). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
temporarily relieves minor pain.
Warnings
For external use only
Do Not Use
- more than 1 patch at a time
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
When Using This Product
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
Stop Use And Ask A Doctor If
- skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- conditions worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- adults and children over 12 years: clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch (see illustration). Apply sticky side of patch to affected area. apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application
- children under 12 years of age: consult a physician.
Other Information
store in a clean, dry place outside of direct sunlight. protect from excessive moisture.
Inactive Ingredients
benzyl alcohol, butylated hydroxyanisole, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexylglycerin, glycerin, kaolin, methacrylate copolymer, oleic acid, phenoxyethanol, polyacrylic acid, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, sodium polyacrylate, sorbitol, tartaric acid, titanium dioxide, water
Questions?
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Principal Display Panel
Lidocaine 4% Pain Relief Patch Label (Lidocaine4pct Aspercreme Painreliefpatch Label)
Maximum Strength
LIDOCAINE
Pain Relief Patch
LIDOCAINE 4% / TOPICAL ANALGESIC
1 Patch 3.93 IN x 5.51 IN (10 cm x 14 cm)
NDC 87236-024-05
Maximum Strength
LIDOCAINE
Pain Relief Patch
LIDOCAINE 4% / TOPICAL ANALGESIC
5 Patches 3.93 IN x 5.51 IN (10 cm x 14 cm)
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