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Americaine

Insight Pharmaceuticals

Americaine Hemorrhoidal Ointment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Hemorrhoidal Ointment

Americaine 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 right away.

Directions

  • 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 Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - Tube Carton

Americaine®
Hemorrhoidal Ointment

Benzocaine
Maximum Strength Hospital Formula

NET WT. 1 OZ (28 G)

Americaine

Americaine

Benzocaine OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-375
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 5.6 g

Inactive Ingredients

Ingredient Name Strength
benzethonium chloride
POLYETHYLENE GLYCOL 300
POLYETHYLENE GLYCOL 3350

Product Characteristics

Color
WHITE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:63736-375-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2009-07-10


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