Americaine: Package Insert and Label Information

AMERICAINE- benzocaine ointment
Insight Pharmaceuticals LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

C hildren under 12 years: ask a doctor

Other i nformation

  • 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)
(click image for full-size original)
AMERICAINE
benzocaine ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-375
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 5.6 g in 28 g
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE
POLYETHYLENE GLYCOL 300
POLYETHYLENE GLYCOL 3350
Product Characteristics
Color WHITE (clear) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-375-01 1 TUBE in 1 BOX contains a TUBE
1 28 g in 1 TUBE This package is contained within the BOX (63736-375-01)
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)

Revised: 01/2020 Insight Pharmaceuticals LLC

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