HONEY LEMON SORE THROAT LOZENGES- benzocaine lozenge 
TopCo

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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Benzocaine 15 mg
Menthol 2.6 mg

Active Ingredients (in each drop)

Benzocaine 15.0 mg

Menthol 2.6 mg

Purposes

Oral anesthetic

Oral anesthetic

Uses

Temporarily relieves the following symptoms:

occasional minor irritation, pain, sore mouth and sore throat

Warnings

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

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.

Stop use and consult doctor if

sore throat is severe, or irritation, pain or redness persists or worsens

sore mouth symptoms do not improve in 7 days

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

Keep out of reach of children.

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

Directions

adults and children 5 years and older - allow 1 lozenge to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a dentist or doctor.

children under 5 years - ask a doctor

Other information

Store at room temperature

Protect from moisture

Inactive ingredients: Corn starch, FD&C yellow #5 (tartrazine), glucose syrup, glycerin, honey, medium chain triglycerides, natural and artificial flavors, propylene glycol, soybean oil, sucrose, and water.

Questions? Call 1-888-423-0139

TopCare Honey Lemon Benzocaine 18ct lozenges

HONEY LEMON SORE THROAT LOZENGES 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-833
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.6 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE15 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize17mm
FlavorHONEY (Honey and Lemon) Imprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-833-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product12/21/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/21/201711/01/2020
Labeler - TopCo (006935977)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco Inc.002149136manufacture(36800-833)

Revised: 11/2018
Document Id: 79a01f0b-d20b-7199-e053-2a91aa0a37a9
Set id: 60dd2d53-ff7b-12fa-e053-2a91aa0a8a8d
Version: 2
Effective Time: 20181101
 
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