WALGREENS MAXIMUM STRENGTH- benzocaine paste, dentifrice

Walgreens by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzocaine 20%

PURPOSE

Purpose

Oral pain reliever

INDICATIONS & USAGE

Use for the temporary relief of pain due to:

• canker sores
• cold sores
• fever blisters
• minor irritation of the mouth and gums
• minor irritation of the mouth and gums caused by dentures or orthodontic appliances

WARNINGS

Warnings

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

• avoid contact with eyes
• do not use more than directed
• do not use for more than 7 days unless told to do so by a dentist or doctor.

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days
• swelling, rash or fever develops
• irritation, pain or redness persists or worsens

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• cut open tip of tube on score mark
• adults and children 2 years of age and older: apply to the affected area 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: ask a dentist or doctor
• for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

OTHER SAFETY INFORMATION

Other information Do not use if tip is cut prior to opening. This preparation is intended for use in cases of toothache, only as a

temporary expedient until a dentist can be consulted. Do not use continuously.

INACTIVE INGREDIENT

Inactive ingredients Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

SPL UNCLASSIFIED SECTION

Questions or comments? 1-877-777-2743

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

MADE IN U.S.A.

PRINCIPAL DISPLAY PANEL

Well at Walgreens

MAXIMUM STRENGTH

Oral Anesthetic Paste

Benzocaine 20% / Oral Pain Reliever

NET WT 0.42 OZ (12 g)

INGREDIENTS AND APPEARANCE

WALGREENS  MAXIMUM STRENGTH
benzocaine paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5337
Route of Administration	TOPICAL

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
MENTHOL (UNII: L7T10EIP3A)
PETROLATUM (UNII: 4T6H12BN9U)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SACCHARIN (UNII: FST467XS7D)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PECTIN (UNII: 89NA02M4RX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor	WINTERGREEN (L Menthol)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-5337-19	1 in 1 CARTON	08/01/2013
1		12 g in 1 TUBE; 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	08/01/2013

Labeler - Walgreens (008965063)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(0363-5337)