WALGREENS SEVERE TOOTHACHE RELIEF- benzocaine paste, dentifrice 
Walgreens

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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Walgreens Max Str Severe Toothache Relief Cream

Active ingredient

Benzocaine 20.0% ...................................................................... Oral pain reliever

Use

for the temporary relief of pain due to: • canker sores • cold sores • fever blisters • minor irritation of the mouth and gums

caused by dentures or orthodontic appliances

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.

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 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 ingredients

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

• 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: consult a dentist or doctor

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Carton label

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Tube Label

WALGREENS  SEVERE TOOTHACHE RELIEF
benzocaine paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5336
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
PETROLATUM (UNII: 4T6H12BN9U)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SACCHARIN (UNII: FST467XS7D)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PECTIN (UNII: 89NA02M4RX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
Color    Score    
ShapeSize
FlavorWINTERGREEN (L Menthol) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-5336-191 in 1 CARTON08/01/201303/06/2019
1NDC:0363-5336-129.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/01/201303/06/2019
Labeler - Walgreens (008965063)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.078584069manufacture(0363-5336)

Revised: 3/2019
 
Walgreens