Active Ingredients
Lidocaine HCL
Menthol
Theracare 4% Lidocaine And 1% Menthol Cream
FDA Label NDC 71101-931
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare 4% Lidocaine And 1% Menthol Cream (NDC 71101-931). 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 ingredients, purposes, 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
Purposes
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
Menthol 1%.......................................................................................................................................Topical analgesic
Use
temporarily relieves minor pain
Warnings
For external use only. Avoid contact with eyes
Do Not Use
■ on large areas of the body 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.
■ do not allow contact with the eyes
■ do not bandage or apply local heat (such as heating pads) to the area of use
Stop Use And Ask A Doctor If
■ condition worsens
■ 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 (800-222-1222) right away.
Directions
adults and children over 12 years:
■ apply a thin layer to affected area, not more than 6 to 8 hours, not exceed 3 applications in a 24 hour period.
children 12 years or younger: ask a doctor
Inactive Ingredients
Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin, Glyceryl monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, Steareth-21, Water
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