Topicale Xtra Gel - Jammin' Strawberry

Benzocaine 20%

Oral Anesthetic

For the temporary relief of minor pain irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedure, minor irritation caused by dentures or orthodontic appliances

Methemoglobinemia warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops pale, grey or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light headedness, fatigue or lack of energy.

Contraindications:

Do not use in large quantities or over large areas of body
Do not use for Teething
Do not use in children under 2 years of age

Allergy Alert:

Do not use if you have a history of allergy to local anesthetics such as benzocaine, butacaine, procaine or other "caine" anesthetics

When using this product

Avoid contact with eyes

In case of accidental overdose, get medical help or contact a Poison Control Centre immediately.

Do not use more than directed.

Stop use and ask a doctor

1. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea or vomiting
2. If sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens

Adults and children 12 years or older - Apply to the affected area. Allow to remain in place at least one minute and the spit out. Use up to 4 times daily or as directed by a dentist or doctor.

Children 2-12 years of age - Should be supervised in the use of the product.

Children under 2 years of age - Do not use.

Do not use if imprinted seal under cap is broken or missing

Store at 68º to 77º F (20º - 25º C)

Benzalkonium Chloride (as a preservative), Carbomers, D&C Red Dye # 40, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium

Peel for Drug Facts

NDC 10733-176-01

Premier

Topicale Xtra

Topical Anesthetic Gel

Benzocaine, 20 %

REF 9007154 Jammin' Strawberry 28.35g (1 o.z.)

For Topical Use only - Not for Injection

Contains: 20 % Benzocaine in a specially designed glycol base

Made in U.S.A.

premierdentalco.com

Manufactured for: Premier® Dental Products Company,
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A.

Mfg: Medical Products Laboratories, Inc.
9990 Global Road Philadelphia, PA 19115 U.S.A.

1120049 MPL Rev5 . 2000267(00)

Questions or Comments?

888.670.6100 or 610.239.6000
M-Th: 7:30a.m. - 5:30p.m., F: 7:30a.m. - 4:00p.m. EST

To obtain an SDS, contact Customer Service Department or visit premierdentalco.com.

Package Carton Package Label

TOPICALE XTRA
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10733-176
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10733-176-01	28.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/17/2022

Labeler - Medical Products Laboratories,Inc. (002290302)