TOPCARE SORE THROAT HONEY LEMON FLAVOR- benzocaine, menthol lozenge 
Topco Associates LLC

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.

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TopCare Honey Lemon Sore Throat Lozenges

TopCare Sore Throat Honey Lemon Flavor

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

Uses

temporarily relieves these symptoms:

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

Other information

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.

TOPCAREHoneyLemonFlavor

TOPCARE SORE THROAT HONEY LEMON FLAVOR 
benzocaine, menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-812
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScoreno score
ShapeROUNDSize23mm
FlavorHONEY, LEMONImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-812-1818 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/25/2014
Labeler - Topco Associates LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Bestco, Inc.002149136manufacture(36800-812)

Revised: 2/2014
Document Id: bdf2e24e-fa41-42bb-b21f-aa043d8ee2e9
Set id: cf54655d-4381-4797-a4e6-adf42ce2c842
Version: 1
Effective Time: 20140225
 
Topco Associates LLC