Otc - Active Ingredient
4% lidocaine
Numbing Cream
FDA Label NDC 85569-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 100 Karma Inc for the product Numbing Cream (NDC 85569-001). 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 - when using, otc - stop use, otc - keep out of reach of children, 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 and itching, associated with minor skin irritations, minor burns, sunburn, minor cuts, scrapes, insect bites.
Warnings
For external use only
Otc - Do Not Use
Do not use this product if
- Pregnant or breastfeeding, ask a health professional before use.
- If there is any allergic reaction to this product.
- In case of accidental overdose, get medical help, or contact the poison control center immediately.
Otc - When Using
- Only take the recommended daily dosage unless otherwise instructed by a doctor.
- Some individuals may experience allergic reactions to the ingredients contained in this product.
Otc - Stop Use
Stop using and ask a doctor
- If discomfort persists for 7 days.
- The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children Avoid contact with eyes.
In case of accidental ingestion, seek medical attention immediately.
Dosage & Administration
- For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
- Apply up to 4 times a day.
- For children under 12 years of age: Consult a doctor.
Other Safety Information
Store at 59°-86°F (15°-30°C). Avoid direct sunlight.
Inactive Ingredient
Carbomer 934, Emu Oil, Arnica, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Benzyl Alcohol, Aqua.
* Please review the disclaimer below.
