Label: NUMFAST TETRACAINE GREEN- tetracaine 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 15, 2018

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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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