Benzocaine by Bellus Medical, LLC BENZOCAINE gel

Benzocaine by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

INACTIVE INGREDIENT

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

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

For external use only. Avoid contact with the eyes.

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

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

PURPOSE

Topical Anesthetic

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZOCAINE 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71888-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71888-101-02	12 in 1 BOX	06/01/2017
1	NDC: 71888-101-01	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(71888-101)