Tetracaine by Bellus Medical, LLC TETRACAINE gel

Tetracaine by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Tetracaine HCL 2%

INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, 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 surfaces and blistered areas.

Stop use and ask a doctor if:

• Skin becomes irritated
• Condition worsens or symptoms last more than 7 days
• Symptoms clear up and reoccur within a few days.

PURPOSE

Topical Anesthetic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TETRACAINE 
tetracaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71888-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE HYDROCHLORIDE	20 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBIC ACID (UNII: X045WJ989B)
EDETATE SODIUM (UNII: MP1J8420LU)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71888-103-02	12 in 1 BOX	06/01/2017
1	NDC: 71888-103-01	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 not final	part348	06/01/2017

Labeler - Bellus Medical, LLC (005677967)

Registrant - Bellus Medical, LLC (005677967)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		965596435	manufacture(71888-103)