LIDOCAINE- lidocaine gel 
Bellus Medical, LLC

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4% Lidocaine Gel

Lidocaine 4%

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, 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 sources or blistered areas.

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.

Topical Anesthetic

Keep put of reach of children.

BLT_4ml_Packet_L_170613 JPEG

LIDOCAINE 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBIC ACID (UNII: X045WJ989B)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71888-102-0212 in 1 BOX06/01/2017
1NDC:71888-102-014 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: fb360897-c462-de3b-e053-6294a90a6e36
Set id: 60cb89f6-e326-0773-e053-2a91aa0a33dd
Version: 2
Effective Time: 20230508
 
Bellus Medical, LLC