Active Ingredient
Lidocaine HCl 4%
Topcare Health Pain Relief Liquid
FDA Label NDC 76162-982
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Health Pain Relief (NDC 76162-982). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
Temporarily relieves minor pain
Warnings
For external use only.
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 and mucous membranes. Do not bandage or apply local heat (such as heating pads) or a medicated patch to 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
and pets. If swallowed, get medical help or contact 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.
Other Information
Store at room temperature.
Inactive Ingredients
acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethylpropanol, 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 acryloyldimethyl taurate copolymer (100000 MPA.S at 1.5%), isohexadecane, phenoxyethanol, SD alcohol, steareth-21, water.
Questions Or Comments?
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Principal Display Panel
Label (Lidocaine Pdp)
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