TOPCARE SORE THROAT HONEY LEMON FLAVOR- benzocaine, menthol lozenge

TopCare Sore Throat Honey Lemon Flavor by

Drug Labeling and Warnings

TopCare Sore Throat Honey Lemon Flavor by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Bestco, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TopCare Sore Throat Honey Lemon Flavor

ACTIVE INGREDIENT

Active ingredients (in each lozenge)	Purpose
Benzocaine 15 mg	Oral anesthetic
Menthol 2.6 mg	Oral anesthetic

Uses

temporarily relieves these symptoms:

• occasional minor irritation, pain, sore mouth and sore throat
• pain associated with canker sores

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics.

Sore throat warning:

Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.

Stop Use and ask a doctor if

• sore throat is severe or irritation, pain or redness persists or worsens
• sore mouth symptom do not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 5 years of age and older: allow 1 lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.

• children under 5 years: ask a doctor

Other information

• store at room temperature
• protect from moisture

Inactive ingredients

glucose syrup, honey, N A Flavoring, propylene glycol, sucrose, water, and  FD C yellow 5 (tartrazine), Soybean oil and corn starch used as processing aids.

Questions or comments?

1-888-423-0139

 TopCare Sore Throat Lozenges Honey Lemon Flavor 18 Count (

36800-812-18)

TopCare

FAST-ACTING RELIEF

Sore Throat

Lozenges

MENTHOL BENZOCAINE

ORAL ANESTHETIC

Fast, soothing, temporary

relief of minor sore throat

pain and Irritation

Honey Lemon Flavor

COMPARE TO CEPACOL

active ingredients

18 LOZENGES

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 ©TOPCO BSS3114

topcare@topco.com

This product is not manufactured or distributed

by Reckftt Bencldser owner af the registered

trademark Cepacol.

INGREDIENTS AND APPEARANCE

TOPCARE SORE THROAT HONEY LEMON FLAVOR 
benzocaine, menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-812
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.6 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
HONEY (UNII: Y9H1V576FH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SOYBEAN OIL (UNII: 241ATL177A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	23mm
Flavor	HONEY, LEMON	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-812-18	18 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/25/2014

Labeler - Topco Associates LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco, Inc.		002149136	manufacture(36800-812)