Label: WALGREENS MOUTH SORE RELIEF- benzocaine liquid
- NDC Code(s): 0363-5334-00
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 12, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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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
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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
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INGREDIENTS AND APPEARANCE
WALGREENS MOUTH SORE RELIEF
benzocaine liquidProduct 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 Products (119559733) Establishment Name Address ID/FEI Business Operations HK Kolmar Canada, Inc 243501959 manufacture(0363-5334) , pack(0363-5334)

