Otc - Active Ingredient
Active ingredient
Lidocaine HCI 2%
The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product Po First Aid Series Burn (NDC 43473-062). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Lidocaine HCI 2%
Purpose
Topical Pain Relief
Uses
Temporary relief of pain associated with minor burns.
Warnings
For external use only.
Do not use
■ in large quantities, particularly over raw or blistered areas
■ near eyes, if this happens rinse thoroughly with water
Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and returns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
■ Apply an even layer of burn gel over deaned affected area not more than 3-4 times daily
■ not to be used on children under 12 years of age.
Inactive ingredients
Aloe Barbadensis Leaf Juice, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.
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