FDA Label for Numbing Cream
View Indications, Usage & Precautions
Numbing Cream Product Label
The following document was submitted to the FDA by the labeler of this product 100 Karma Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine 5%
Menthol 0.7%
Otc - Purpose
Local Anesthetic
Local Anesthetic
Indications & Usage
For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.
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 ingredientscontained in this product.
- Never put it into the rectum by using the finger or any medical device.
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
- Keep away from direct sunlight or heat.
- Store at room temperature 59~-86°F(15°-30°C).
Inactive Ingredient
Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.
Package Label.Principal Display Panel
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