Label: KROGER MAXIMUM STRENGTH- benzocaine cream

  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated July 29, 2016

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  • 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

  • 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

    • do not use more than directed
    • for more than 7 days unless told to do so by a dentist or doctor

    Stop use and ask a doctor if

    • swelling rash or fever developes
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days
    • allergic reaction occurs

    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 tubne on score mark
    • adults and children 2 years of age and older; apply a small amount of product to the cavity and arround the gum surrounding the teeth
    • 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.

  • 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 temporary expedient until a dentist can be consulted
    • do not use continuously
    • this formula will stay in place for an extended duration of relief
    • avoid using toothpaste or drinking softdrinks or fruit juices for at least one hour after applying
  • Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    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.

  • PRINCIPAL DISPLAY PANEL

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    MM2.jpg

  • INGREDIENTS AND APPEARANCE
    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)