Drug Facts

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)

PRINCIPAL DISPLAY PANEL:

Americaine®
Benzocaine
Hemorrhoidal Ointment

NET WT. 1 OZ (28 G)

AMERICAINE
benzocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-375
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.6 g in 28 g

Ingredient Name	Strength
Inactive Ingredients
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63736-375-01	1 in 1 BOX	07/10/2009
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M015	07/10/2009

Labeler - Insight Pharmaceuticals LLC (055665422)

Americaine Hemorrhoidal Ointment