CHERRY SORE THROAT LOZENGES- benzocaine lozenge 
DZA Brands 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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Benzocaine 15 mg
Menthol 3.6 mg

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

Purpose

Oral anesthetic

Oral anesthetic

Uses temporarily relieves these symptoms:

occasional minor irritation, pain, sore mouth and sore throat

pain associated with canker sores

Warnings

Sore throat warning: severe of persistent sore throat or sore throat accompanied by high 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 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 ask a doctor

Inactive ingredients: corn starch*, FD&C Red 40, glucose syrup, glycerin*, medium chain triglycerides*, natural & artificial flavors, propylene glycol, soybean oil*, sucrose, and water. *May contain these ingredients.

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

Healthy Accents Cherry Benzocaine 18ct

CHERRY SORE THROAT LOZENGES 
benzocaine lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-027
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) MENTHOL3.6 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScorescore with uneven pieces
ShapeROUNDSize17mm
FlavorCHERRYImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-027-1818 in 1 BLISTER PACK; Type 0: Not a Combination Product01/27/2016
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/27/201601/01/2021
Labeler - DZA Brands LLC (090322194)
Registrant - BestCo Inc. (002149136)
Establishment
NameAddressID/FEIBusiness Operations
BestCo Inc.002149136manufacture(55316-027)

Revised: 10/2018
 
DZA Brands LLC