Lidocaine by Bellus Medical, LLC LIDOCAINE gel

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by Bellus Medical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%

INACTIVE INGREDIENT

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA.

DOSAGE & ADMINISTRATION

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

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

DO NOT USE: In large quantities particularly over raw sources or blistered areas.

INDICATIONS & USAGE

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.

PURPOSE

Topical Anesthetic

KEEP OUT OF REACH OF CHILDREN

Keep put of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71888-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71888-102-02	12 in 1 BOX	06/01/2017
1	NDC: 71888-102-01	4 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	06/01/2017

Labeler - Bellus Medical, LLC (005677967)

Registrant - Bellus Medical, LLC (005677967)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA		965596435	manufacture(71888-102)