5820344 Top Care Oral Pain Relief Liquid

Drug Facts

Active ingredient

Benzocaine 20.0% (w/w)

Purpose

Oral anesthetic

Uses

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

toothache
sore gums
canker sores
braces
minor dental procedures

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.

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

Other information

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

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS?

1-888-423-0139

topcare@topco.com

MADE IN CANADA

Card R4

TOPCARE MAXIMUM STRENGTH
benzocaine liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-443-58	1 in 1 BLISTER PACK	10/01/2014
1		14.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	10/01/2014

Labeler - Topco Associates LLC (006935977)

Registrant - Lornamead Inc. (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
HK KOLMAR CANADA, INC		243501959	manufacture(36800-443) , pack(36800-443)