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HealthWise Pain Relief Cream with 4% Lidocaine, 1.75 oz
Drug Facts
Healthwise Pain Relief Cream With Lidocaine Cream
FDA Label NDC 71101-932
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 Healthwise Pain Relief Cream With Lidocaine (NDC 71101-932). 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 other, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCI 4%
Purpose
Lidocaine HCl 4%............................................................................................................................Topical anesthetic
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 warning 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 (1-800-222-1222) right away.
Directions
adults and children over 12 years:
■ apply a thin layer to the affected area every 6 to 8 hours, not to 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, cyclomethicone 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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