CVS  MAXIMUM STRENGTH- benzocaine paste, dentifrice 
CVS Pharmacy

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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5820321 CVS Max Str Oral Pain Reliever Paste

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to

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 the eyes
  • do not use more than directed
  • do not use for more than 7 days unless directed 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

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.

Carton R6

CVS   MAXIMUM STRENGTH
benzocaine paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-123
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:59779-123-191 in 1 CARTON01/20/2011
112 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/20/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(59779-123)

Revised: 1/2023
Document Id: f32d1a51-a635-6430-e053-2a95a90a7504
Set id: 8691d6b6-741e-47b2-8332-76742b34715f
Version: 8
Effective Time: 20230126
 
CVS Pharmacy