ANESTHETIC LOZENGES HONEY LIME FLAVORS- benzocaine,menthol lozenge 
PRASON FOODS

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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Active Ingredient

Benzocaine   15 mg

Menthol        2.6 mg

Purpose

Oral anesthetic

Uses

Temporarily relieves occasional minor irritation, pain, sore throat and sore mouth.

Warning

Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduced 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

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 persist or worsens, see your dentist or doctor promptly.

Do not use

Stop use and ask doctor if


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.

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

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

TEMPER EVIDENT PACKAGING. DO NOT USE IF OUTER BOX OR BLISTER IS OPENED OR DAMAGED.

Inactive ingredients

Acesulfame k, Citric acid, Honey lime flavor, Liquid glucose, Sucrose, Tartaric acid, Tartrazine and Water

Product label

image descriptionimage description

ANESTHETIC LOZENGES HONEY LIME FLAVORS 
benzocaine,menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83348-002
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
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
SUCROSE (UNII: C151H8M554)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
TARTARIC ACID (UNII: W4888I119H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize18mm
FlavorHONEY (Honey and Lime) Imprint Code NO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83348-002-0110 in 1 CARTON04/15/2023
19 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/15/2023
Labeler - PRASON FOODS (861707089)
Establishment
NameAddressID/FEIBusiness Operations
PRASON FOODS861707089manufacture(83348-002)

Revised: 5/2023
Document Id: fab61465-dfeb-0498-e053-6294a90a9aec
Set id: fb997cec-3025-4ca4-bd9a-b0331b1a6a2a
Version: 1
Effective Time: 20230502
 
PRASON FOODS