FAMILY DOLLAR ORAL PAIN RELIEF (BENZOCAINE) LIQUID [FAMILY DOLLAR SERVICES INC.]

FAMILY DOLLAR ORAL PAIN RELIEF (BENZOCAINE) LIQUID [FAMILY DOLLAR SERVICES INC.]
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NDC 55319-388-81
Set ID ddd0a678-3cee-42a1-a34e-a870e2dd4a4f
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc.
Generic Name
Product Class
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20% (W/W)

  • PURPOSE

    Purpose

    Oral anesthetic

  • INDICATIONS & USAGE

    Use

    Temporarily relieves pain associated with the following mouth and gum irritations:

    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
  • WARNINGS

    Warnings

    Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray, or blue colored skin(cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    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

    Do not use

    • more than directed
    • for more than 7 days unless told to do so by a dentist or doctor
    • for teething
    • in children under 2 years of age

    Stop use and ask a doctor if

    • swelling, rash or fever develops
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older:

    • apply to affected 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: do not use

  • STORAGE AND HANDLING

    Other information

    • do not use if package has been opened
    • store at 20 - 25 C (68-77F)
  • INACTIVE INGREDIENT

    Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA

    DISTRIBUTED BY:

    MIDWOOD BRANDS, LLC

    10611 MONROE RD.

    MATTHEWS, NC 28105

  • PRINCIPAL DISPLAY PANEL

    Card R2FAMILY WELLNESS

    MAXIMUM STRENGTH

    Oral Pain Relief

    20% Benzocaine

    Liquid Anesthetic

    0.5 FL OZ (14.7 mL)

  • INGREDIENTS AND APPEARANCE
    FAMILY DOLLAR  ORAL PAIN RELIEF
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-388
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colororange (orange to reddish orange) Score    
    ShapeSize
    FlavorPINEAPPLE (Pina Colada Flavor 26041) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-388-821 in 1 CARTON08/01/2013
    114.7 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/01/2013
    Labeler - Family Dollar Services Inc. (024472631)
    Registrant - Lornamead (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSR Cosmetic Solutions Inc.243501959manufacture(55319-388)

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