Label: BURN SOLUTION CREAM- tetracaine cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 27, 2018

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  • 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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