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NDC 63736-0378-02 Americaine 11.4 g/57g Details

Americaine 11.4 g/57g

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

Product Information

NDC	63736-0378
Product ID	63736-378_a964404f-73c4-4fd2-abb3-c78ac8273255
Associated GPIs	90850010003220
GCN Sequence Number	071102
GCN Sequence Number Description	benzocaine AEROSOL 20 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	34792
HICL Sequence Number	001516
HICL Sequence Number Description	BENZOCAINE
Brand/Generic	Brand
Proprietary Name	Americaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	TOPICAL
Active Ingredient Strength	11.4
Active Ingredient Units	g/57g
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 NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63736-0378-02 (63736037802)

Pricing Information	N/A
NDC Package Code	63736-378-02
Billing NDC	63736037802
Package	57 g in 1 CAN (63736-378-02)
Marketing Start Date	2009-07-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4fd14452-0285-40c4-b835-36935c2056b2 Details

SPL UNCLASSIFIED SECTION

Americaine®

Benzocaine

Topical Anesthetic Spray

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Topical Anesthetic

Uses

temporarily relieves pain and itching associated with:

minor cuts
scrapes
minor burns
insect bites

Warnings

For external use only

Flammability Warning

Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens, or symptoms persists for more than 7 days
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

shake can well, hold 6" to 12" from affected area; spray liberally.
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: consult a physician

Inactive ingredients

Polyethylene glycol 300

Propellant: Isobutane, normal butane, propane

Store at room temperature 15°– 25°C (59°– 77°F).

Questions?

1-800-344-7239

PRINCIPAL DISPLAY PANEL - 2 OZ Spray Label

Americaine®

Benzocaine

Topical Anesthetic Spray

NET WT. 2 OZ (57 G)

INGREDIENTS AND APPEARANCE

AMERICAINE

benzocaine aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-378
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	11.4 g in 57 g

Ingredient Name	Strength
Inactive Ingredients
ISOBUTANE (UNII: BXR49TP611)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPANE (UNII: T75W9911L6)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63736-378-02	57 g in 1 CAN; Type 0: Not a Combination Product	07/14/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	07/14/2009

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020

Document Id: a964404f-73c4-4fd2-abb3-c78ac8273255

Set id: 4fd14452-0285-40c4-b835-36935c2056b2

Version: 6

Effective Time: 20200114