Otc - Active Ingredient
Lidocaine HCl 4%
Walgreens Cool N Heat Lidocaine Gel
FDA Label NDC 0363-7801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co for the product Walgreens Cool N Heat Lidocaine (NDC 0363-7801). 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 - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, 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 the temporary relief of pain.
Warnings
For external use only.
Flammable.Keep away from fire or flame.
Do not use inlarge quantities, particularly over raw surfaces or blistered areas.
When using this product
- avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
- do not apply to wounds or damaged skin
- do not bandage tightly
- condition worsens
- symptoms last more than 7 days or clear up and occur again with a few days
- redness or irritation develops
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Clean affected area before applying product. Adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years old, ask a doctor.
Inactive Ingredient
Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf extract, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21 water.
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