NDC 10223-0217

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 ID10223-0217_5e116134-85fa-4b04-9795-d55a361b07de
NDC10223-0217
Product TypeHuman Prescription Drug
Proprietary NameCetacaine Topical Anesthetic
Generic NameBenzocaine, Butamben, And Tetracaine Hydrochloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date1960-01-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameCetylite Industries, Inc.
Substance NameBENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE
Active Ingredient Strength0 g/.2g; g/.2g; g/.2g
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Ester Local Anesthetic [EPC], Esters [CS], Increased Histamine Release [PE], Local Anesthesia [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 10223-0217-3

1 JAR in 1 BOX (10223-0217-3) > 32 g in 1 JAR
Marketing Start Date1960-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10223-0217-3 [10223021703]

Cetacaine Topical Anesthetic GEL
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1960-01-01

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE.028 g/.2g

OpenFDA Data

SPL SET ID:9777acbb-8166-4734-9932-dc66b05bfcb5
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    10223-0217Cetacaine Topical AnestheticBenzocaine, Butamben, and Tetracaine Hydrochloride
    10223-0221Cetacaine Topical AnestheticBenzocaine, Butamben, and Tetracaine Hydrochloride
    10223-0201Cetacaine AnestheticBenzocaine, Butamben, and Tetracaine Hydrochloride
    10223-0202Cetacaine AnestheticBenzocaine, Butamben, and Tetracaine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.