TETRACAINE- tetracaine gel 
Bellus Medical, LLC

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2% Tetracaine Gel

Tetracaine HCL 2%

Water, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA

Uses : For the temporary relief of discomfort and pain associated with

Directions : Adults and Children 12 years of age and older Apply to affected area not more than 3-4 times daily.

Warnings : For external use only. Avoid contact with the eyes.

DO NOT USE : In large quantities, particularly over raw surfaces and blistered areas.

Stop use and ask a doctor if:

Topical Anesthetic

Keep out of reach of children.

Uses : For the temporary relief of discomfort and pain associated with

Directions : Adults and Children 12 years of age and older Apply to affected area not more than 3-4 times daily.

BLT_4ml_Packet_T_170613 JPEG

TETRACAINE 
tetracaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71888-103-0212 in 1 BOX06/01/2017
1NDC:71888-103-014 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/01/2017
Labeler - Bellus Medical, LLC (005677967)
Registrant - Bellus Medical, LLC (005677967)

Revised: 5/2023
Document Id: fb35ff9c-6ea7-474a-e053-6394a90ab4cb
Set id: 60cabb5f-606b-7a74-e053-2a91aa0ac024
Version: 2
Effective Time: 20230508
 
Bellus Medical, LLC