WALGREENS MOUTH SORE RELIEF- benzocaine liquid

Walgreens Mouth Sore Relief by

Drug Labeling and Warnings

Walgreens Mouth Sore Relief by is a Otc medication manufactured, distributed, or labeled by Walgreens, Lornamead, Inc, HK Kolmar Canada, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

PURPOSE

Oral anesthetic/analgesic

INDICATIONS & USAGE

for the temporary relief of pain due to the canker sores, minor irritation of the mouth and gums caused by dentures or othodontic appliances, or minor injury of the mouth or gums

WARNINGS

Methemoglobinemia warning: use of this product may cuase methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oygen 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:

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

adults and children 2 years of age and over: to assure formation of long0lasting film coating, dry affected area and apply medication undiluted with a cotton swab or fingertip; allow a few seconds for coating to for; use up to 4 times daily, or as directed by a dentist or doctor

children under 12 years of age should be supervised in the use of this product

children under 2 years of age: do not use

INACTIVE INGREDIENT

benzyl alcohol, cetylpyridinium chloride, compound benzoin tincture, dimethyl isosorbide, ethylcellulose, flavor, octylacylamide/acrylates/butylaminoethyl/methylacrylate copolymer, oleth-10, polyethylene glycol, propylene glycol, ricinus communis (castor) seed oil , SD alcohol 38B, sucralose, tannic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS MOUTH SORE RELIEF 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5334
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OLETH-10 (UNII: JD797EF70J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
BENZOIN, (+/-)- (UNII: L7J6A1NE81)
ACRYLATE/BUTYLAMINOETHYL METHACRYLATE/METHYL ACRYLATE/METHYL METHACRYLATE/OCTYLACRYLAMIDE COPOLYMER (40000 WAMW) (UNII: 8RZ43KFB5K)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
ALCOHOL (UNII: 3K9958V90M)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
TANNIC ACID (UNII: 28F9E0DJY6)

Product Characteristics
Color	brown (Light to dark brown)	Score
Shape		Size
Flavor	MINT (alcohol and mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-5334-00	1 in 1 BLISTER PACK	12/01/2024
1		14.7 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/31/2024

Labeler - Walgreens (008965063)

Registrant - Lornamead, Inc (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
HK Kolmar Canada, Inc		243501959	manufacture(0363-5334) , pack(0363-5334)