ZILACTIN EARLY RELIEF COLD SORE- benzyl alcohol gel

Zilactin by

Drug Labeling and Warnings

Zilactin 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

Benzyl alcohol 10%

Purpose

Cold sore/fever blister treatment, Oral pain reliever

Use

temporarily relieves pain caused by:

• cold sores/fever blisters
• canker sores, mouth sores
• gum irritations

Warnings

Flammable:

• keep away from fire or flame

Stop use and ask a physician if

• sore mouth symptoms do not improve in 7 days
• condition worsens or symptoms clear up and occur again within a few 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 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 to film, and immediately wipe the area with a moist gauze pad or tissue.
• contains alcohol 68% by volume
• store at 15-30°C (59-86°F)

Inactive ingredients

boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, 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

Cold Sore/Fever Blister/Oral Pain Treatment

Zilactin® Early Relief Cold Sore Gel

• Bioadhesive Promotes Healing
• Relieves Pain for up to 6 Hours

Net wt. 0.25 oz (7.1g)

INGREDIENTS AND APPEARANCE

ZILACTIN   EARLY RELIEF COLD SORE
benzyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50486-468
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzyl alcohol (UNII: LKG8494WBH) (benzyl alcohol - UNII:LKG8494WBH)	benzyl alcohol	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)
eucalyptol (UNII: RV6J6604TK)
thymol (UNII: 3J50XA376E)
menthol (UNII: L7T10EIP3A)
tannic acid (UNII: 28F9E0DJY6)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50486-468-02	1 in 1 CARTON	06/30/2005
1		7.1 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	06/30/2005

Labeler - Blairex Laboratories, Inc. (092575133)