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HealthWise 4% Lidocaine Pain Relief Roll-on
Healthwise Roll-on Lidocaine Pain Relief Liquid
FDA Label NDC 71101-003
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 Roll-on Lidocaine Pain Relief Liquid (NDC 71101-003). 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, uses, warnings, 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
Active Ingredient
Lidocaine 4%
Purpose
Topical analgesic
Uses
temporarily relieves minor pain
Warnings
For external use only
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 and mucus 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
Flammable■ Keep away from fire or flame
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 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
acrylates/C10-30 alkyl acrylate crosspolymer (6000 MPA.S), capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol, triethanolamine, water
Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethyl propanol, ceteth-10 phosphate, cetostearyl alcohol, Cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone
crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane,
phenoxyethanol, SD alcohol, steareth-21, water
Questions Or Comments
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