FDA.reportPublic FDA data

Americaine Hemorrhoidal Ointment

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:40:38

Label at a glance#

ProductAmericaine
Active ingredientBENZOCAINE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms associated with hemorrhoids inflammation itching local pain soreness

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Hemorrhoidal Ointment

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms associated with hemorrhoids

  • inflammation
  • itching
  • local pain
  • soreness

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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 INGREDIENT SECTION

benzethonium chloride, PEG-75, polyethylene glycol 300.

QUESTIONS?

OTC - QUESTIONS SECTION

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.

PRINCIPAL DISPLAY PANEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Americaine® 
Benzocaine
Hemorrhoidal Ointment

NET WT. 1 OZ (28 G)

A close-up of a label AI-generated content may be incorrect.A close-up of a label AI-generated content may be incorrect.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1426293Americaine Hemorrhoidal 20 % Topical OintmentPSN6
244557benzocaine 20 % Topical OintmentPSN6
1426293benzocaine 0.2 MG/MG Topical Ointment [Americaine Hemorrhoidal]SBD6
244557benzocaine 0.2 MG/MG Topical OintmentSCD6
1426293Americaine Hemorrhoidal 0.2 MG/MG Topical OintmentSY6
1426293Americaine Hemorrhoidal 20 % Topical OintmentSY6
244557benzocaine 20 % Topical OintmentSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-375-01Americaine28 g in 1 TUBEOINTMENT286
63736-375-01Americaine1 in 1 BOXOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63736-375-01GM - Gram63736-375509a3589-ef43-4500-b39d-10830113663312022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51
Benzethonium ChlorideINACTIVE INGREDIENTPH41D057441
Polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQ1
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5P1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-37563736-375-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
BENZETHONIUM CHLORIDEPH41D05744IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
PEG-75G2M7P15E5PIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-25full-release2026-06-01 00:39:43

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5POINTMENT / TOPICAL1179 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzethonium ChlorideBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
Polyethylene glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / TOPICAL1114 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyethylene glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQOINTMENT / TOPICAL1114 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzethonium ChlorideBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmericaineBENZOCAINEInsight Pharmaceuticals LLCd13c022f-2f91-40b4-bd66-0cfc0e147a5f2025-10-23WarningsExact identifier
ndc (package): 63736-375-01
ndc (product): 63736-375
ndc11 (package): 63736037501
spl id: 41746b33-0ff3-4b02-8018-34e4fd54ef7b
spl set id: d13c022f-2f91-40b4-bd66-0cfc0e147a5f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.