FDA Label for Americaine
View Indications, Usage & Precautions
Americaine Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. 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
Benzocaine 20%
Purpose
Hemorrhoidal Ointment
Uses
temporarily relieves these symptoms associated with hemorrhoids
- inflammation
- itching
- local pain
- soreness
Warnings
For external use only
When Using This Product
- certain persons can develop allergic reactions to ingredients in this product
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- do not exceed dosage unless directed by a doctor
Stop Use And Ask A Doctor If
- condition worsens or does not improve in 7 days
- bleeding occurs
- symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults
- when practical, cleanse affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
- apply externally to the affected area up to 6 times daily
Children under 12 years: ask a doctor
Other Information
- if ointment contacts clothing or other fabrics, wash in warm water only; do not use bleach.
- store at room temperature 15°– 25°C (59°– 77°F)
- tube is sealed for your protection. Do not use if foil seal is broken or missing.
Inactive Ingredients
benzethonium chloride, polyethylene glycol 300, polyethylene glycol 3350.
Questions?
Call 1-800-344-7239 or visit our website at www.insightpharma.com
Distributed by: Insight Pharmaceuticals LLC
Tarrytown, NY 10591
A Prestige Brands Company
Principal Display Panel:
Americaine®
Benzocaine
Hemorrhoidal Ointment
NET WT. 1 OZ (28 G)
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