20/20 TOPICAL ANESTHETIC- benzocaine strip

20/20 by

Drug Labeling and Warnings

20/20 by is a Otc medication manufactured, distributed, or labeled by Advanced Dental Anesthetics, Atlas Operations Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Remove 1 strip from carrying case.
• Place strip onto area of desired anesthesia
• Allow strip to dissolve completely

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.

SPL UNCLASSIFIED SECTION

Distributed by:
Advanced
DENTAL ANESTHETICS

PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label

Active Ingredient: Benzocaine 20%

20/20
Topical Anesthetic Strip

24 STRIPS

INGREDIENTS AND APPEARANCE

20/20   TOPICAL ANESTHETIC
benzocaine strip

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76484-948
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN (Light Green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76484-948-24	1 in 1 POUCH
1		24 in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part356	02/28/2012

Labeler - Advanced Dental Anesthetics (969804223)

Establishment
Name	Address	ID/FEI	Business Operations
Atlas Operations Inc		946369055	MANUFACTURE, PACK, LABEL