BURN SOLUTION CREAM (TETRACAINE CREAM) CREAM [BURN SOLUTION FOUNDATIONS]

BURN SOLUTION CREAM (TETRACAINE CREAM) CREAM [BURN SOLUTION FOUNDATIONS]
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NDC 70704-212-34, 70704-212-35
Set ID 3a5cf648-cc76-620e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Burn Solution Foundations
Generic Name
Product Class
Product Number
Application Number PART348
  • DRUG FACTS

    Topical Burn Cream Plus Pain Relief

  • Active Ingredient Purpose

    Tetracaine (1.0%).......................Pain & Itch Relief

  • Purpose

    • For temporary relief of minor aches and pains of muscles and joints commonly assoicated with backache, arthritis, strains, bruises, sprains, and burns.

  • Indications

    • For cooling, deep-penetrating pain relief, apply a thin layer sparingly to affected areas.
    • Apply up to 3 times daily.

  • Warnings

    • Not for use on children under 2 years old except as directed by a doctor.
    • Avoid contact with the eyes.
    • For external use only.
    • If irritation develops and persists, discontinue use and consult a doctor.
    • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Apply this product topically to affected areas.
    • Use up to 3 times daily.
    • Use only as directed.

  • Other Information

    External Anesthetic

  • Inactive Ingredients

    Water, Stearic Acid, Lauramide DEA, Beeswax, Propylene Glycol, Sodium Tetraborate, Sodium Lauryl Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Eucalyptus Oil.

  • Questions or Comments

    Burn Solution Foundation

    Land O Lakes, Florida

    8am - 5pm M-F

    Phone: (813) 803-3876

    Internet: www.burnsolutionfoundation.com

  • PRINCIPAL DISPLAY PANEL

    burnsolutioncream

  • INGREDIENTS AND APPEARANCE
    BURN SOLUTION CREAM 
    tetracaine cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70704-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BORATE ANHYDROUS (UNII: 8191EN8ZMD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70704-212-3512 in 1 BOX08/23/2016
    1NDC:70704-212-3410 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/23/2016
    Labeler - Burn Solution Foundations (085996883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(70704-212)

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