Otc - Active Ingredient
Lidocaine HCl 4%
Lidocaine Pain Relief Roll-on Liquid
FDA Label NDC 82645-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Lidocaine Pain Relief Roll-on (NDC 82645-013). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, stop use and ask a doctor if, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
For temporarily relief of pain and itching.
Warnings
For External Use Only.
When using this product:
use only as directed
do not bandage tightly
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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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: do not use, consult a doctor.
Inactive Ingredient
acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf extract, aminomethyl propanol, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, cyclopentasiloxane (and) C30-45 alkyl cetearyl dimethicone crosspolymer, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, SD alcohol 40, steareth-21, purified water
Otc - Questions
1-833-551-0932
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