TOPICALE XTRA- benzocaine gel 
Medical Products Laboratories,Inc.

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.

----------

Topicale Xtra Gel - Very Berry Cherry

Benzocaine 20%

Oral Anesthetic

For the temporary relief of minor pain and irritation associated with minor injury of the mouth and gums, canker sores, minor dental procedures, minor irritation of the mouth and gums 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

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

Stop use and ask a doctor

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

Do not use more than directed.


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.

Benzalkonium Chloride (as a preservative), Carbomers, D&C Red Dye # 33, Flavorings, Polyethylene Glycol, Purified Water, Saccharin Sodium

Peel for Drug Facts

NDC 10733-174-01


Premier


Topicale Xtra


Topical Anesthetic Gel


Benzocaine, 20 %


REF 9007152 Very Berry Cherry 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.


1120047 MPL Rev5 . 2000263(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 CartonPackage Label

TOPICALE XTRA 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10733-174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Listed under NDC # 10733-175-01) , CHERRY, STRAWBERRY (Listed under NDC # 10733-176-01) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10733-174-0128.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2022
Labeler - Medical Products Laboratories,Inc. (002290302)

Revised: 7/2023
Document Id: 01556923-4b0c-549b-e063-6294a90a18ad
Set id: 9452bff4-8c08-eff9-e053-2a95a90a67ed
Version: 3
Effective Time: 20230725
 
Medical Products Laboratories,Inc.