NUMFAST TETRACAINE GREEN (TETRACAINE) CREAM [UNIT DOSE, LTD.]

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NUMFAST TETRACAINE GREEN (TETRACAINE) CREAM [UNIT DOSE, LTD.]
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NDC 67194-020-01
Set ID 77d9e6ea-1cd3-4447-ba74-01cd7143e27c
Category HUMAN OTC DRUG LABEL
Packager Unit Dose, Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredient

    Tetracaine 2% w/w

    Purpose

    Local Anesthetic

  • Uses:

    Temporarily relieves pain from minor scrapes

  • WARNINGS

    For External Use only

    When using this product

    • Do not get into the eyes
    • Do not use more than directed
    • Do not swallow

    Stop use and ask a doctor if

    • pain worsens or does not improve within 7 days or cleans up and appears again in a few days
    • ​you develop an allergy

    Keep out of reach of children

    • If swallowed, get medical help right away or contact a Poison Control Center right away.
  • Directions:

    ​Children under 12 years-ask a doctor

    • Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.
  • Questions?

    ​Call toll free 888/452-4946

  • Inactive Ingredients:

    Water (Aqua), Mineral Oil, Petrolatum, Stearyl Alcohol, Propylene Glycol, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Disodium EDTA, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Blue 1, Yellow 10, BHT

  • Package Labeling:

    Numfast 1Outer

  • INGREDIENTS AND APPEARANCE
    NUMFAST TETRACAINE GREEN 
    tetracaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67194-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67194-020-0115 g in 1 JAR; Type 0: Not a Combination Product01/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/20/2016
    Labeler - Unit Dose, Ltd. (119080393)
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