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NDC 63736-0375-01 Americaine 5.6 g/28g Details

Americaine 5.6 g/28g

Americaine is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is BENZOCAINE.

Product Information

NDC	63736-0375
Product ID	63736-375_272a1b21-943a-4bbc-acfd-2a5e3433ef05
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Americaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	5.6
Active Ingredient Units	g/28g
Substance Name	BENZOCAINE
Labeler Name	Insight Pharmaceuticals LLC
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63736-0375-01 (63736037501)

Pricing Information	N/A
NDC Package Code	63736-375-01
Billing NDC	63736037501
Package	1 TUBE in 1 BOX (63736-375-01) / 28 g in 1 TUBE
Marketing Start Date	2009-07-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d13c022f-2f91-40b4-bd66-0cfc0e147a5f Details

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

AMERICAINE

benzocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-375
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.6 g in 28 g

Ingredient Name	Strength
Inactive Ingredients
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)

Product Characteristics
Color	WHITE (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63736-375-01	1 in 1 BOX	07/10/2009
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part346	07/10/2009

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020

Document Id: 272a1b21-943a-4bbc-acfd-2a5e3433ef05

Set id: d13c022f-2f91-40b4-bd66-0cfc0e147a5f

Version: 4

Effective Time: 20200114