TOPICALE- benzocaine gel

Topicale by

Drug Labeling and Warnings

Topicale by is a Otc medication manufactured, distributed, or labeled by Medical Products Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 18%

PURPOSE

Oral Anesthetic

INDICATIONS & USAGE

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

WARNINGS

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 lightheadedness, 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.

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

DOSAGE & ADMINISTRATION

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.

OTHER SAFETY INFORMATION

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

• Store at 68º to 77º F (20º - 25º C)

INACTIVE INGREDIENT

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

INFORMATION FOR OWNERS/CAREGIVERS

NDC: 10733-166-35

Premier

Topicale

Topical Anesthetic Gel

Benzocaine, 18 %

REF 9007161 35g Jar

Tropical Fruit

Made in U.S.A.

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.

0518005 Rev3 MPL 317931

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 www.premusa.com.

Retain drug facts for future reference.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPICALE 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10733-166
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	180 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color		Score
Shape		Size
Flavor	TROPICAL FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10733-166-35	35 g in 1 CARTON; Type 0: Not a Combination Product	03/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/05/2019

Labeler - Medical Products Laboratories, Inc. (002290302)