BENZOCAINE- benzocaine gel 
Bellus Medical, LLC

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20% Benzocaine Gel

Benzocaine 20%

EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid

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.

For external use only. Avoid contact with the eyes.

Stop use and ask a doctor if:

DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.

Topical Anesthetic

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.

Keep out of reach of children.

BLT_4ml_Packet_B_170613

BENZOCAINE 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBIC ACID (UNII: X045WJ989B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71888-101-0212 in 1 BOX06/01/2017
1NDC:71888-101-014 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: fb35fa5b-c50b-1b94-e053-6394a90a8379
Set id: 60cafbaf-8ec6-46a5-e053-2a91aa0af11f
Version: 2
Effective Time: 20230508
 
Bellus Medical, LLC