Americaine Ointment
FDA Label NDC 63736-375

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Americaine (NDC 63736-375). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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® Benzocainehemorrhoidal Ointmentnet Wt. 1 Oz (28 G) (Americaine Hemorrhoidal Ointment 01)

Principal Display Panel:americaine® Benzocainehemorrhoidal Ointmentnet Wt. 1 Oz (28 G) (Americaine Hemorrhoidal Ointment 01)

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