NDC 10223-0221

Cetacaine Topical Anesthetic

Benzocaine, Butamben, And Tetracaine Hydrochloride

Cetacaine Topical Anesthetic is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Cetylite Industries, Inc.. The primary component is Benzocaine; Butamben; Tetracaine Hydrochloride.

• Product ID: 10223-0221_5e116134-85fa-4b04-9795-d55a361b07de
• NDC: 10223-0221
• Product Type: Human Prescription Drug
• Proprietary Name: Cetacaine Topical Anesthetic
• Generic Name: Benzocaine, Butamben, And Tetracaine Hydrochloride
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 1960-01-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Cetylite Industries, Inc.
• Substance Name: BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
• Active Ingredient Strength: 0 g/.2g; g/.2g; g/.2g
• Pharm Classes: Allergens [CS], Cell-mediated Immunity [PE], Ester Local Anesthetic [EPC], Esters [CS], Increased Histamine Release [PE], Local Anesthesia [PE], Standardized Chemical Allergen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 10223-0221-1

1 JAR in 1 BOX (10223-0221-1) > 32 g in 1 JAR

• Marketing Start Date: 1960-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10223-0221-1 [10223022101]

Cetacaine Topical Anesthetic GEL

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1960-01-01

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	.028 g/.2g

OpenFDA Data

• SPL SET ID: 9777acbb-8166-4734-9932-dc66b05bfcb5
• Manufacturer:
  • Cetylite Industries, Inc.
• UNII:
  • U3RSY48JW5
  • EFW857872Q
  • 5NF5D4OPCI
• RxNorm Concept Unique ID - RxCUI:
  • 308645
  • 209970

Pharmacological Class

• Standardized Chemical Allergen [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]

NDC Crossover Matching brand name "Cetacaine Topical Anesthetic" or generic name "Benzocaine, Butamben, And Tetracaine Hydrochloride"

NDC	Brand Name	Generic Name
10223-0217	Cetacaine Topical Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride
10223-0221	Cetacaine Topical Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride
10223-0201	Cetacaine Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride
10223-0202	Cetacaine Anesthetic	Benzocaine, Butamben, and Tetracaine Hydrochloride