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Zilactin Early Relief Cold Sore

Dosage form: gel
Ingredients: benzyl alcohol 0.1g in 1g
Labeler: Blairex Laboratories, Inc.
NDC Code: 50486-468

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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)

ZILACTIN   EARLY RELIEF COLD SORE
benzyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50486-468
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzyl alcohol (benzyl alcohol) benzyl alcohol0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
boric acid 
Hydroxypropyl Cellulose (Type M) 
propylene glycol 
salicylic acid 
alcohol 
eucalyptol 
thymol 
menthol 
tannic acid 
water 
Packaging
#Item CodePackage Description
1NDC:50486-468-021 TUBE in 1 CARTON
17.1 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/30/2005
Labeler - Blairex Laboratories, Inc. (092575133)

 
Blairex Laboratories, Inc.

Medically reviewed on Aug 27, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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