ZILACTIN-B- benzocaine gel

Zilactin-B by

Drug Labeling and Warnings

Zilactin-B by is a Otc medication manufactured, distributed, or labeled by Blairex Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Use

temporarily relieves pain caused by:

• canker sores
• minor mouth sores and gum irritations
• denture and brace pain

Warnings

Flammable:

• keep away from fire or flame

Allergy Alert:

• do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

Stop use and ask a physician if

• sore mouth symptoms do not improve in 7 days
• swelling, rash or fever develops
• irritation, pain or redness persists or worsens
• apply only to affected area
• do not exceed recommended dosage
• avoid contact with the eyes
• do not use for more than 7 days unless directed by a physician or dentist

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

• adults and children 2 years and older: Dry affected area. Apply a thin coat of gel with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds.
• children under 12 years: adult supervision should be given in the use of this product
• children under 2 years: do not use, consult a physician or dentist

Other information

• do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin-B Long Lasting Mouth Sore Gel to film, and immediately wipe the area with a moist gauze pad or tissue.
• contains alcohol 65% by volume
• store at 15-30°C (59-86°F)

Inactive ingredients

Boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 38-B, tannic acid

Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA

QUESTIONS

Questions or Comments?
Call TOLL FREE 1-800-252-4739
www.zilactin.com

PRINCIPAL DISPLAY PANEL

PROMOTES HEALING

Oral Pain Reliever

Zilactin®-B 6 Hour Canker & Mouth Sore Relief

• Bioadhesive Promotes Healing
• Eat and Drink Pain-Free for up to 6 Hours

Net wt. 0.25 oz (7g)

INGREDIENTS AND APPEARANCE

ZILACTIN-B 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50486-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5)	benzocaine	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
boric acid (UNII: R57ZHV85D4)
hydroxypropyl cellulose (type M) (UNII: U3JF91U133)
propylene glycol (UNII: 6DC9Q167V3)
salicylic acid (UNII: O414PZ4LPZ)
alcohol (UNII: 3K9958V90M)
peppermint oil (UNII: AV092KU4JH)
tannic acid (UNII: 28F9E0DJY6)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50486-550-32	1 in 1 CARTON	06/29/2005
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/29/2005

Labeler - Blairex Laboratories, Inc. (092575133)