CVS PHARMACY  MAXIMUM STRENGTH- benzocaine gel, 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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5820329 CVS Max Str Oral Anesthetic Gel

Active ingredient

Benzocaine 20%

Purpose

Oral anesthetic

Use

temporarily relieves pain associated with mouth and gum irritations

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

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

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

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

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

Card R5

CVS PHARMACY   MAXIMUM STRENGTH
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-582
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Characteristic Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-582-091 in 1 CARTON01/20/2011
19 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 finalpart35601/20/2011
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(59779-582)

Revised: 1/2023
Document Id: f32d514e-0e72-9f99-e053-2995a90ad370
Set id: 92747826-cf58-4406-b3b5-12f7c7077c2c
Version: 6
Effective Time: 20230126
 
CVS Pharmacy