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CVS Pharmacy Maximum Strength by CVS Pharmacy

Medically reviewed on August 6, 2018

Dosage form: gel, dentifrice
Ingredients: BENZOCAINE 20.0g in 100g
Labeler: CVS Pharmacy
NDC Code: 59779-582

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% w/w...................................................................... Oral anesthetic

Use

temporarily relieves pain associated with mouth and gum irritations

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 exceed recommended dosage. do not use for more than 7 days unless directed by doctor / dentist

  • Stop use and ask a dentist or doctor if sore mouth symptoms do not get better in 7 days, irritation, pain or redness persists or worsens swelling, rash or fever develops

Keep out of reach of children. if more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

to open tube, cut tip of tube on score mark. adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by dentist/doctor. children under 12 years of age: adult supervision should be given in the use of this product.

children under 2 years of age: consult a doctor / dentist. for denture irritation apply a thin layer to the affected area; do not reinsert dental work intil irritation/pain is relieved; rinse mouth well after reinserting

Other Information

Store at 20-25C (68-77F). Do not refrigerate

Inactive ingredients

Blue 1, Carbomer, Flavor, Glycerin, Polyethylene Glycol, Propylene Glycol, Red 40, Sodium Saccharin, Sorbic Acid, Water, Yellow 10

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CVS PHARMACY  MAXIMUM STRENGTH
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-582
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SORBIC ACID 
GLYCERIN 
FD&C RED NO. 40 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Characteristic Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-582-091 TUBE (TUBE) in 1 CARTON
1NDC:59779-582-029.0 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/20/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIOperations
Lornamead126440440manufacture(59779-582), pack(59779-582)

 
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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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