NDC 80069-011

SJ3

Lidocaine Hcl, Tetracaine Hcl, Benzocaine

SJ3 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Dermal Source, Inc.. The primary component is Benzocaine; Lidocaine Hydrochloride; Tetracaine Hydrochloride.

Product ID80069-011_191febfc-65a7-4bf2-ae1a-3923e2d64c22
NDC80069-011
Product TypeHuman Otc Drug
Proprietary NameSJ3
Generic NameLidocaine Hcl, Tetracaine Hcl, Benzocaine
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2021-08-15
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart348
Labeler NameDermal Source, Inc.
Substance NameBENZOCAINE; LIDOCAINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE
Active Ingredient Strength120 mg/mL; mg/mL; mg/mL
Pharm ClassesAllergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Ester Local Anesthetic [EPC], Esters [CS], Increased Histamine Release [PE], Local Anesthesia [PE], Local Anesthesia [PE], Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 80069-011-01

118.294 mL in 1 BOTTLE, PUMP (80069-011-01)
Marketing Start Date2021-08-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "SJ3" or generic name "Lidocaine Hcl, Tetracaine Hcl, Benzocaine"

NDCBrand NameGeneric Name
80069-005SJ3Lidocaine HCl, Tetracaine HCl, Benzocaine
80069-011SJ3Lidocaine HCl, Tetracaine HCl, Benzocaine
80069-006Super TLidocaine HCl, Tetracaine HCl, Benzocaine
80069-010Super TLidocaine HCl, Tetracaine HCl, Benzocaine
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.