Benzocaine 15 mg Menthol 2.6 mg

Leader Honey Lemon Benzocaine Throat Lozenge by

Drug Labeling and Warnings

Leader Honey Lemon Benzocaine Throat Lozenge by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Bestco LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER HONEY LEMON BENZOCAINE THROAT LOZENGE- benzocaine lozenge 
Cardinal Health

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Benzocaine 15 mg
Menthol 2.6 mg

Active ingredient (in each lozenge)

Benzocaine 15 mg

Menthol 2.6 mg

Purpose

Oral anesthetic

Oral anesthetic

Uses temporarily relieves these symptoms:

• occasional minor irritation, pain, sore mouth and sore throat

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

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.

Do not use

• for teething
• in children under 2 years of age

Stop use and ask 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 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 two hours as necessary or as directed by a doctor.

children under 5 years - do not use

Other information:

• store at room temperature
• protect from moisture
• Contains FD&C yellow No. 5 (tartrazine) as a color additive

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

Questions? Call 1-800-245-2898, Monday through Friday, 9AM - 4PM EST

LEADER HONEY LEMON BENZOCAINE THROAT LOZENGE 
benzocaine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0553
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	17mm
Flavor	HONEY (Honey Lemon)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0553-1	18 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/08/2020	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/08/2020	09/01/2023

Labeler - Cardinal Health (063997360)

Registrant - Bestco LLC (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco LLC		002149136	manufacture(70000-0553)

Revised: 10/2023

Document Id: 08175e5f-e02d-25be-e063-6394a90a2a31

34390-5

Set id: a7969a81-5280-0633-e053-2995a90ac11d

Version: 3

Effective Time: 20231019