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.

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20/20 Topical Anesthetic Strip

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: 1 strip, not more than 4 per day

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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (3 MPA.S) (UNII: 9H4L916OBU) 18.44 mg
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ACACIA (UNII: 5C5403N26O)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)  
Product Characteristics
ColorGREEN (Light Green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76484-948-241 in 1 POUCH
124 in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35602/28/2012
Labeler - Advanced Dental Anesthetics (969804223)
Establishment
NameAddressID/FEIBusiness Operations
Atlas Operations Inc946369055MANUFACTURE, PACK, LABEL

Revised: 5/2012
Document Id: 55480e63-4b5c-4230-905b-5edfc1f7bb18
Set id: 0584e235-34f8-4d53-aa7c-ac11e01ac456
Version: 2
Effective Time: 20120508
 
Advanced Dental Anesthetics