Cetacaine Anesthetic (Page 2 of 2)

Use in Pregnancy

Safe use of Cetacaine has not been established with respect to possible adverse effects upon fetal development. Therefore, Cetacaine should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Cetacaine is used.

Contraindications

Do not use Cetacaine Spray or Cetacaine Liquid to treat infants or children younger than 2 years.

Cetacaine is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Cetacaine should not be applied to large areas of denuded or inflamed tissue. Cetacaine should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient.

Cetacaine should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine.

Autoclavable Cannula for Cetacaine Spray

  • The supplied 4″ stainless steel cannula for Cetacaine Spray is specially designed for accessibility and application of Cetacaine, at the required site of pain control. Replacement cannulas are available as a 10-pack (Item # 0205).

Luer-lock Syringes and Microcapillary Delivery Tips for Cetacaine Liquid

  • Cetacaine Liquid Syringes and Microcapillary Delivery Tips are supplied with the Cetacaine Liquid Chairside Kit (Item # 0218) and Clinical Kit (Item # 0212). They also can be purchased separately. Syringes are available in packs of 50 (Item # 0219S) or packs of 100 (Item # 0214). Delivery Tips are available in packs of 50 (Item # 0219T) or packs of 100 (Item # 0213).

How Supplied

  • Cetacaine Spray, 20 g bottle, including propellant 1 (Item # 0220, NDC 10223-0201-3) which includes one cannula.
  • Cetacaine Spray Single Patient Use, 5 g bottle, including propellant 1 (Item # 0222, NDC 10223-0201-4) which includes one cannula.
  • Cetacaine Liquid Chairside Kit (Item # 0218 NDC 10223-0202-6) which includes one 14 g bottle of Cetacaine Liquid with Luer-lock dispenser cap, 20 syringes and 20 delivery tips.
  • Cetacaine Liquid Clinical Kit (Item # 0212, NDC 10223-0202-5) which includes one 30 g bottle of Cetacaine Liquid with Luer-lock dispenser cap, 100 syringes and 100 delivery tips.
  • Cetacaine Liquid, 14 g bottle (Item # 0203, NDC 10223-0202-2) with Luer-lock dispenser cap.
  • Cetacaine Liquid, 30 g bottle (Item # 0211, NDC 10223-0202-4) with Luer-lock dispenser cap.

1
WARNING
Cetacaine Spray contains CFC-114 and CFC-11, substances which harm public health and environment by destroying ozone in the upper atmosphere. The propellant leak rate of Cetacaine Spray does not meet the USP requirements.

Made in USA

Cetylite Industries, Inc.
Pennsauken, NJ 08110

Rev. 10 /18

www.cetylite.com

PRINCIPAL DISPLAY PANEL — 30 g Bottle Box

NDC 10223-0202-4
Item No. 0211

Cetacaine®
Topical Anesthetic
LIQUID

With Luer-lock
Dispenser Cap

30g

Control Pain
Effective Only on
Mucous Membrane

CETYLITE®

PRINCIPAL DISPLAY PANEL -- 30 g Bottle Box
(click image for full-size original)
CETACAINE ANESTHETIC
benzocaine, butamben, and tetracaine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10223-0202
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
Dipropylene glycol
Saccharin
Benzalkonium chloride
Mecetronium Bromide
Product Characteristics
Color Score
Shape Size
Flavor BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10223-0202-2 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 14 g in 1 BOTTLE, GLASS This package is contained within the BOX (10223-0202-2)
2 NDC:10223-0202-4 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
2 30 g in 1 BOTTLE, GLASS This package is contained within the BOX (10223-0202-4)
3 NDC:10223-0202-5 1 BOTTLE, GLASS in 1 KIT contains a BOTTLE, GLASS
3 30 g in 1 BOTTLE, GLASS This package is contained within the KIT (10223-0202-5)
4 NDC:10223-0202-6 1 BOTTLE, GLASS in 1 KIT contains a BOTTLE, GLASS
4 14 g in 1 BOTTLE, GLASS This package is contained within the KIT (10223-0202-6)
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 (10223-0202), ANALYSIS (10223-0202), LABEL (10223-0202), PACK (10223-0202)

Revised: 01/2019 Cetylite Industries, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.