TANAC- benzocaine liquid 
Insight Pharmaceuticals LLC

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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Tanac®
NO STING LIQUID

Drug Facts

Active Ingredient

Benzocaine 10%

Purpose

Oral pain reliever

Uses

temporarily relieves pain due to:

  • canker sores
  • cold sores
  • fever blisters
  • minor irritations or injury of the mouth and gums

Warnings

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.

When using this product

  • avoid contact with the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask a dentist or doctor if

  • sore mouth symptoms do not improve in 7 days
  • symptoms clear up and occur again within a few days
  • irritation, pain or redness persists or worsens
  • swelling, rash, or fever develops

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • remove imprinted safety seal from bottle cap
 Adults and children 2 years of age and older Apply product with cotton swab or clean fingertip to the affected area. Use up to 4 times daily or as directed by a dentist or doctor
 Children under 12 years of age Should be supervised in the use of this product
 Children under 2 years of age Ask a dentist or doctor

Other information

Do not use if imprinted bottle seal is broken or missing prior to opening. Keep carton for full drug facts.

Inactive ingredients

benzalkonium chloride, peppermint oil, polyethylene glycol 400, propylene glycol, sodium saccharin, tannic acid

Questions?

call 1-800-344-7239

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 13 mL Bottle Carton

TRUSTED BY PHARMACISTS

Fast, Soothing
Relief Of Painful
Mouth Sores

• Canker Sores • Gum Irritations
• Cold Sores • Fever Blisters

Benzocaine 10% / Oral Pain Reliever

PRINCIPAL DISPLAY PANEL - 13 mL Bottle Carton
TANAC 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE1.3 mg  in 13 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TANNIC ACID (UNII: 28F9E0DJY6)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-011-2424 in 1 CASE01/01/201108/31/2017
11 in 1 CARTON
113 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34801/01/201108/31/2017
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 7/2010
Document Id: f8999233-536d-4588-a7a6-42681fd078af
Set id: 4fec813b-f5ad-4d15-8db5-529d5aa8bcb6
Version: 2
Effective Time: 20100729
 
Insight Pharmaceuticals LLC