TOPCARE MAXIMUM STRENGTH- benzocaine liquid

Topcare by

Drug Labeling and Warnings

Topcare by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Lornamead Inc., CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20.0% (w/w)

PURPOSE

Purpose

Oral anesthetic

INDICATIONS & USAGE

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

• toothache
• sore gums
• canker sores
• braces
• minor dental procedures

WARNINGS

Warnings

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

When using this product

• avoid contact with eyes
• do not exceed recommended dosage
• do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask doctor or dentist if

• sore mouth symptoms do not improve in 7 days
• irritation, pain or redness persists or worsens
• swelling, rash or fever develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older:
• apply to affected area using applicator tip
• use up to 4 times daily or as directed by a dentist or doctor
• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor

STORAGE AND HANDLING

Other information

• do not use if package has been opened
• store at 20 - 25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS?

1-888-423-0139

topcare@topco.com

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

Top Care®

MAXIMUM STRENGTH

Oral Pain Relief

LIQUID ORAL ANESTHETIC

20% BENZOCAINE

0.5 FL OZ (14.7 mL)

INGREDIENTS AND APPEARANCE

TOPCARE  MAXIMUM STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-443
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	red (dark orange/red to sl brown)	Score
Shape		Size
Flavor	MINT (N&A Mint Flavor 619179)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-443-48	1 in 1 BLISTER PACK	10/01/2014
1		14.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/01/2014

Labeler - Topco Associates LLC (006935977)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	manufacture(36800-443) , pack(36800-443)