ZILACTIN-B- benzocaine gel 
Blairex Laboratories, Inc.

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.

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Drug Facts

Active ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Use

temporarily relieves pain caused by:

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

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

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

PROMOTES HEALING

Oral Pain Reliever

Zilactin ®-B 6 Hour Canker & Mouth Sore Relief

Net wt. 0.25 oz (7g)

Principal Display Panel
ZILACTIN-B 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50486-550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50486-550-321 in 1 CARTON06/29/2005
17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/29/2005
Labeler - Blairex Laboratories, Inc. (092575133)

Revised: 11/2021
Document Id: d17abbc0-8870-6c82-e053-2995a90a5940
Set id: 34ce5d91-35ff-4f2c-9d6b-ac389895b6b2
Version: 4
Effective Time: 20211123
 
Blairex Laboratories, Inc.