FDA Label for Lidocaine
View Indications, Usage & Precautions
Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Shinpharma 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.
Active Ingredient
Lidocaine 5%
Purpose
Anorectal (Hemorrhoidal)
Uses
For temporary relief of local discomfort, itching, soreness or burning in the perianal area associated with anorectal disorders
Warnings
For external use only
When Using This Product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- allergic reaction occurs
- rectal bleeding occurs
- redness, irritattion, swelling, pain or other symptoms begin or increase
- condition worsens or does not improve within 7 days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times a day. Children under 12 years: Consult a doctor.
Other Information
- always keep the tube tightly closed
- store at temperatures not exceeding 15°C - 30°C (59°F - 86°F)
- protect from freezing
Inactive Ingredients
Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water
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