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Lidocaine by Bellus Medical, LLC

Medically reviewed on December 20, 2017

Dosage form: gel
Ingredients: LIDOCAINE 4g in 100mL
Labeler: Bellus Medical, LLC
NDC Code: 71888-102

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

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

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

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.

LIDOCAINE 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCERIN 
PROPYLENE GLYCOL 
XANTHAN GUM 
ALOE VERA LEAF 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
SORBIC ACID 
EDETATE SODIUM (EDETIC ACID)  
Packaging
#Item CodePackage Description
1NDC:71888-102-0212 PACKET in 1 BOX
1NDC:71888-102-014 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34806/01/2017
Labeler - Bellus Medical, LLC (005677967)
Registrant - Bellus Medical, LLC (005677967)
Establishment
NameAddressID/FEIOperations
Filltech USA965596435manufacture(71888-102)

 
Bellus Medical, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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