KROGER MAXIMUM STRENGTH (BENZOCAINE) CREAM [KROGER]

KROGER MAXIMUM STRENGTH (BENZOCAINE) CREAM [KROGER]
PDF | XML

NDC 30142-354-02, 30142-354-09
Set ID d6340d05-d0cb-491e-ab4e-d7669a613e78
Category HUMAN OTC DRUG LABEL
Packager Kroger
Generic Name
Product Class
Product Number
Application Number PART356
  • 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

    MM1.jpg

    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)

Related Drugs