Dosage & Administration
Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.
The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Lidocaine Pain Relief Roll-on (NDC 0395-9130). 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 dosage & administration, inactive ingredient, otc - active ingredient, warnings, otc - keep out of reach of children, indications & usage, otc - purpose, cvs label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylparaben, polysorbate 60, SD alcohol 40 (15%), steareth-2, steareth-21, water
Lidocaine 4%
For External Use Only.
When using this product:
use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes
do not apply to wounds or damaged skin
do not use in large quantities
partifcularly over raw surfaces or blistered areas
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
For temporarily relief of pain and itching.
Topical analgesic
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