Cetacaine Topical Anesthetic (Page 2 of 2)

How Supplied

Cetacaine Topical Anesthetic Gel (Strawberry), 32 g jar
NDC 10223-0217-3
Item# 0217

Cetacaine Topical Anesthetic Gel (Mint), 32 g jar
NDC 10223-0221-1
Item# 0221

Made in USA

Cetylite Industries, Inc.
Pennsauken, NJ 08110
www.cetacaine.com

Rev. 10/18

PRINCIPAL DISPLAY PANEL — 32 g Jar Box — Strawberry

NDC 10223-0217-3
Item# 0217

Cetacaine ®
Topical Anesthetic GEL

(14% Benzocaine, 2% Butamben, and 2% Tetracaine Hydrochloride)

Indicated for anesthesia of all
accessible mucous membrane
except the eyes.

Strawberry Flavor

Net Contents: 32 g

Rev. 02/17

PRINCIPAL DISPLAY PANEL -- 32 g Jar Box -- Strawberry
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 32 g Jar Box — Mint

NDC 10223-0221-1
Item# 0221

Cetacaine ®
Topical Anesthetic GEL

(14% Benzocaine, 2% Butamben, and 2% Tetracaine Hydrochloride)

Indicated for anesthesia of all
accessible mucous membrane
except the eyes.

Cool Mint Flavor

Net Contents: 32 g

Rev. 02/17

PRINCIPAL DISPLAY PANEL -- 32 g Jar Box -- Mint
(click image for full-size original)
CETACAINE TOPICAL ANESTHETIC
benzocaine, butamben, and tetracaine hydrochloride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10223-0217
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 0.028 g in 0.2 g
Butamben (Butamben) Butamben 0.004 g in 0.2 g
Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride 0.004 g in 0.2 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol, Unspecified
Saccharin
Benzalkonium chloride
Mecetronium bromide
Water
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10223-0217-3 1 JAR in 1 BOX contains a JAR
1 32 g in 1 JAR This package is contained within the BOX (10223-0217-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1960
CETACAINE TOPICAL ANESTHETIC
benzocaine, butamben, and tetracaine hydrochloride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10223-0221
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 0.028 g in 0.2 g
Butamben (Butamben) Butamben 0.004 g in 0.2 g
Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride 0.004 g in 0.2 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol, Unspecified
Saccharin
Benzalkonium chloride
Mecetronium bromide
Water
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10223-0221-1 1 JAR in 1 BOX contains a JAR
1 32 g in 1 JAR This package is contained within the BOX (10223-0221-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1960
Labeler — Cetylite Industries, Inc. (001283704)
Establishment
Name Address ID/FEI Operations
Cetylite Industries, Inc. 001283704 MANUFACTURE (10223-0217), MANUFACTURE (10223-0221), ANALYSIS (10223-0217), ANALYSIS (10223-0221), LABEL (10223-0217), LABEL (10223-0221), PACK (10223-0217), PACK (10223-0221)

Revised: 01/2019 Cetylite Industries, Inc.

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