Purpose
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
Aspercreme Lidocaine Foot (diabetic) Cream
FDA Label NDC 41167-0597
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 Lidocaine Foot (diabetic) (NDC 41167-0597). 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 purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
temporarily relieves minor pain
Warnings
For external use only
Do Not Use
■ if you have serious foot problems, such as ulcers or infections
■ if you have numbness or reduced ability to feel pain
■ 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 warning on this carton.
■ do not allow contact with the eyes and the mucous membranes
■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
■ do not use at the same time as other topical analgesics
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
If Pregnant Or Breast-Feeding,
ask a health 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:
■ apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
■ massage into painful area until thoroughly absorbed into skin
children 12 years or younger: ask a doctor
Inactive Ingredients
water, alcohol denat. (10%), cetearyl alcohol, ceteth-20 phosphate, dimethicone, caprylyl methicone, dicetyl phosphate, glyceryl stearate, aloe barbadensis leaf juice, panthenol, tocopheryl acetate, magnesium ascorbyl phosphate, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethylhexylglycerin, methylparaben, disodium EDTA, citric acid
333-105
Child-resistant packaging. Close cap tightly after use.
Principal Display Panel
Max Strength
Aspercreme
Lidocaine
2 in 1
Pain Relief + Moisturization
foot cream
Principal Display Panelmax Strengthaspercremelidocaine2 In 1pain Relief + Moisturizationfoot Cream (Aspercreme Lidocaine Foot Cream Diabetic 01)
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