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.
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.
- 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).
- 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).
- 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.
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
Item No. 0211
Effective Only on
| CETACAINE ANESTHETIC |
benzocaine, butamben, and tetracaine hydrochloride solution
|Labeler — Cetylite Industries, Inc. (001283704)|
|Cetylite Industries, Inc.||001283704||MANUFACTURE (10223-0202), ANALYSIS (10223-0202), LABEL (10223-0202), PACK (10223-0202)|
Revised: 01/2019 Cetylite Industries, Inc.
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