20/20  TOPICAL ANESTHETIC - benzocaine strip 
Advanced Dental Anesthetics

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

Benzocaine 20%

Purpose

Oral pain reliever

Use

Temporary relief of oral pain

Warnings

Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug.

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.

KEEP OUT OF REACH OF CHILDREN.

This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Stop use and ask doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days

Directions

Not for use by individuals under 12 years of age.

Dosage: as per dentist or doctor

Other

Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT

Inactive ingredients

Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.

Distributed by:
Advanced
DENTAL ANESTHETICS

PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label

Active Ingredient: Benzocaine 20%

20/20
Topical Anesthetic Strip

24 STRIPS

PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label

20/20   TOPICAL ANESTHETIC
benzocaine strip
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76484-948
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (3 MPA.S)18.44 mg
HYPROMELLOSE 2208 (100 MPA.S) 
HYPROMELLOSE 2208 (4000 MPA.S) 
GLYCERIN 
PEPPERMINT OIL 
ACACIA 
CARBOXYMETHYLCELLULOSE SODIUM 
SUCRALOSE 
POLYSORBATE 80 
SODIUM COPPER CHLOROPHYLLIN 
Product Characteristics
ColorGREEN (Light Green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76484-948-241 CASE ( CASE) in 1 POUCHcontains a CASE
124 STRIP ( STRIP) in 1 CASEThis package is contained within the POUCH (76484-948-24)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35602/28/2012

Labeler - Advanced Dental Anesthetics (969804223)
Establishment
NameAddressID/FEIOperations
Atlas Operations Inc946369055MANUFACTURE, PACK, LABEL

Revised: 01/2012 Advanced Dental Anesthetics