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Walgreens Maximum Strength by walgreens

Dosage form: paste, dentifrice
Ingredients: BENZOCAINE 20g in 100g
Labeler: walgreens
NDC Code: 0363-8130

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.

Drug Facts

Active ingredient

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

Use

for the temporary relief of pain due to toothache

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

  • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.
  • Stop use and ask a doctor if 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 scoremark

  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. CDhildren 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.

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 tempory expedient until a dentist can be consulted. Do not use continuously. This formula will stay in place for extended duration of relief.

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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WALGREENS  MAXIMUM STRENGTH
benzocaine paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL 
PETROLATUM 
GELATIN 
POLYETHYLENE GLYCOL 1000 
SACCHARIN 
METHYL SALICYLATE 
PECTIN 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorWINTERGREEN (L Menthol) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-8130-091 TUBE (BOTTLE) in 1 CARTON
1NDC:0363-8130-0212.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/20/2011
Labeler - walgreens (008965063)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture(0363-8130), pack(0363-8130)

Revised: 04/2011
 
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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