WALGREENS SEVERE ORAL PAIN RELIEVER- benzocaine liquid

Walgreens by

Drug Labeling and Warnings

Walgreens by is a Otc medication manufactured, distributed, or labeled by Walgreens, Lornamead Inc., CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20.0% (w/w)

PURPOSE

Purpose

Oral anesthetic/analgesic

INDICATIONS & USAGE

Use

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

WARNINGS

Warnings

For oral use only
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

When using this product

• do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• to assure formation of long lasting film coating, dry affected area and apply medication undiluted with applicator.
• allow a few seconds for coating to form.
• use up to 4 times daily, or as directed by a dentist or doctor.
• children 12 years of age should be supervised in the use of this product.
• children under 2 years of age: ask a dentist or doctor

STORAGE AND HANDLING

Other information

• do not purchase if package has been opened
• store at 20 - 25 C (68-77F)
• close cap tightly after use to avoid evaporation
• avoid contact with eyes
• avoid contact with clothing and household furniture surfaces to avoid possible staining
• this is a personal care item, and should be used by one individual only

INACTIVE INGREDIENT

Inactive ingredients

Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamideacrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose, Tannic Acid.

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DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

MADE IN CANADA

PRINCIPAL DISPLAY PANEL

Well at Walgreens

PROFESSIONAL STRENGTH

Mouth Sore Relief

Benzocaine 20% / Oral Anesthetic Liquid

0.5 FL OZ (14.7 mL)

INGREDIENTS AND APPEARANCE

WALGREENS  SEVERE ORAL PAIN RELIEVER
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5335
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
TANNIC ACID (UNII: 28F9E0DJY6)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OLETH-10 (UNII: JD797EF70J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
BENZOIN RESIN (UNII: GK21SBA74R)

Product Characteristics
Color	yellow (orange to reddish orange)	Score
Shape		Size
Flavor	MINT (Mint Flavor #25797)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-5335-51	1 in 1 BLISTER PACK	01/10/2012
1		14.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/10/2012

Labeler - Walgreens (008965063)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	manufacture(0363-5335)