AMERICAINE- benzocaine ointment

Americaine by

Drug Labeling and Warnings

Americaine by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

AMERICAINE 
benzocaine ointment

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	07/10/2009

Labeler - Insight Pharmaceuticals LLC (055665422)