Otc - Active Ingredient
Lidocaine 4%
Nupharmisto 4% Lidocaine Numbing Cream
FDA Label NDC 85833-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Everymarket Inc for the product Nupharmisto 4% Lidocaine Numbing Cream (NDC 85833-007). 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, dosage & administration, warnings, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local Anesthetic
Dosage & Administration
For the temporary relief of pain and itchin associated with minor burns, sunburn, minor cuts, scrapes, and insect bites.
Warnings
For external use only
Stop and ask a doctor if
- an llergic reaction occurs.
- symptom does not improve or if redness, irritation, swelling, pain or other symptoms develop or increase.
Otc - When Using
do not exceed the recommended daily dosage unless directed by a doctor. Avoid contact with the eyes. Do not use if you are allergic to the ingredients in this product or if the seal is broken or missing.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Indications & Usage
- For children under 12, consult a doctor.
- For adults: If possible, clean the affected area with mild soap and warm water, making sure to rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
- Apply up to 4 times daily.
Other Safety Information
Store room temperature 59°-86°F(15°-30°C). Keep away from direct sunlight or heat.
Inactive Ingredient
DI Water, Dimethyl Isosorbide,Ethylhexyl Palmitate,Hydrogenated Polydecene,Propylene Glycol, Arnica Montana Flower Extract,Helianthus Annuus (Sunflower)Seed Oil, Emu Oil, Menthol,Phenoxyethanol, Sodium Polyacrylate, Trideceth-6,Menthol, Acrylates/C10-30 AlkylAcrylate Crosspolymer,Allantoin, Tocopheryl Acetate,Ethylhexylglycerin, Tetrasodium EDTA.
Otc - Questions
Contact us at [email protected]
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