Americaine Hemorrhoidal Ointment

Americaine Hemorrhoidal Ointment
SPL v6
SPL
SPL Set ID d13c022f-2f91-40b4-bd66-0cfc0e147a5f
Route
TOPICAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (5.6 g)
Inactive Ingredients
Benzethonium Chloride Polyethylene Glycol 300 Peg-75

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-07-10

Description

Drug Facts

Purpose

Hemorrhoidal Ointment


Medication Information

Purpose

Hemorrhoidal Ointment

Description

Drug Facts

Uses

temporarily relieves these symptoms associated with hemorrhoids

  • inflammation

  • itching

  • local pain

  • soreness
Section 42229-5

Drug Facts

Warnings

For external use only .

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

Questions?

Call 1-800-344-7239

www.prestigebrandsinc.com/products

Distributed by: Insight Pharmaceuticals LLC

Tarrytown, NY 10591

A Prestige Brands Company 

AMUS002101 Made in China.

©2022 Trade dress is owned by Medtech Products Inc.

All rights reserved.

Active Ingredient

Benzocaine 20%

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)

  • TAMPER EVIDENT: tube is sealed for your protection. Do not use if foil seal is broken or missing.
Inactive Ingredients

benzethonium chloride, PEG-75, polyethylene glycol 300.

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
Principal Display Panel:



Americaine ® 

Benzocaine

Hemorrhoidal Ointment



NET WT. 1 OZ (28 G)

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.


Structured Label Content

Uses

temporarily relieves these symptoms associated with hemorrhoids

  • inflammation

  • itching

  • local pain

  • soreness
Section 42229-5 (42229-5)

Drug Facts

Purpose

Hemorrhoidal Ointment

Warnings

For external use only .

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

Questions? (QUESTIONS?)

Call 1-800-344-7239

www.prestigebrandsinc.com/products

Distributed by: Insight Pharmaceuticals LLC

Tarrytown, NY 10591

A Prestige Brands Company 

AMUS002101 Made in China.

©2022 Trade dress is owned by Medtech Products Inc.

All rights reserved.

Active Ingredient (Active ingredient)

Benzocaine 20%

Other Information (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)

  • TAMPER EVIDENT: tube is sealed for your protection. Do not use if foil seal is broken or missing.
Inactive Ingredients (Inactive ingredients)

benzethonium chloride, PEG-75, polyethylene glycol 300.

When Using This Product (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
Principal Display Panel: (PRINCIPAL DISPLAY PANEL:)



Americaine ® 

Benzocaine

Hemorrhoidal Ointment



NET WT. 1 OZ (28 G)

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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