Active Ingredient
Lidocaine 4%
Aspercreme With Lidocaine Patch
FDA Label NDC 41167-0585
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Aspercreme With Lidocaine (NDC 41167-0585). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant 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 anesthetic
Use
temporarily relieves minor pain
Warnings
For external use only
Do Not Use
■ more than 1 patch on your body at a time 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 carton/label. (change as appropriate)
■ do not allow contact with the eyes and mucous membranes
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not use at the same time as other topical analgesics
■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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.
Directions
adults and children over 12 years:
■ clean and dry affected area
■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
■ use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
Inactive Ingredients
aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water
Principal Display Panel
Aspercreme
Lidocaine
Patch XL
Principal Display Panelaspercremelidocainepatch Xl (Aspercreme With Lidocaine Patch Xl 01)
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