Active Ingredient
Lidocaine HCl 4%
Roll-on Pain Relief Liquid Gel
FDA Label NDC 42507-916
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Roll-on Pain Relief Liquid (NDC 42507-916). 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, 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
Purpose
Topical Analgesic
Use
Temporarily relieves minor pain
Warnings
For External use only
Do Not Use
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
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
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 And Pets.
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
Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, am nomethylpropanol, 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 acryloyld methyl taurate copolymer (100000 MPA.S at 1.5%), sohexadecane, phenoxyethanol, SD alcohol, steareth-21, water
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