KROGER MAXIMUM STRENGTH- benzocaine cream 
Kroger
Reference Label Set Id: 9c40aed8-3d77-422b-b34a-b3d8cd18c54d
Reference Label Set Id: dbb3b85c-063a-4dc6-9adc-16e48f5bd268

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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Drug Facts

Active ingredient

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

Menthol 0.25% .......................................Oral pain reliever

Benzalkonium Chloride 0.1% ....................Antiseptic

Uses

for the temporary relief of pain due to toothaches

to help protect against infection of minor oral irritation

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

Stop use and ask a doctor if

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Children under 2 years of age: ask a dentist or doctor.

Other Information

Inactive ingredients

Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin

Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
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: ask a dentist or doctor.

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KROGER  MAXIMUM STRENGTH
benzocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-354
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20.00 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.1 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PECTIN (UNII: 89NA02M4RX)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Product Characteristics
Colorwhite (off white to beige tan) Score    
ShapeSize
FlavorWINTERGREEN (Characteristic wintergreen) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-354-091 in 1 CARTON07/29/2016
1NDC:30142-354-029.3 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/29/2016
Labeler - Kroger (006999528)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(30142-354) , pack(30142-354)

Revised: 7/2016
Document Id: 0252f7bc-2e61-412d-877c-0413feea660f
Set id: d6340d05-d0cb-491e-ab4e-d7669a613e78
Version: 1
Effective Time: 20160729
 
Kroger