ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]

ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]
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NDC 27789-911-02
Set ID d072243f-6ba6-4ab6-8ebf-a2381fa9c2df
Category HUMAN OTC DRUG LABEL
Packager PHI, Inc
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Zcaine Fast Acting Anesthetic Gel


  • Drug Facts


  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses:

    For the temporary relief of discomfort and pain associated with

    • minor burns and skin irritations
    • minor cuts and scrapes
    • itching
  • Warnings:

    For external use only.

    Avoid contact with eyes.


    Do not use In large quantities, particularly over raw surfaces or blistered areas


    Stop use and ask a doctor if

    • skin becomes irritated
    • condition worsens or symptoms last more than 7 days
    • symptoms clear up and reoccur within a few days
  • Keep out of reach of children


  • Directions

    Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

  • Other Ingredients:

    Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

  • Zcaine Fast Acting Anesthetic Gel 2oz/60g

    ZcaineTubeZcaineFrontPanel

  • INGREDIENTS AND APPEARANCE
    ZCAINE FAST ACTING ANESTHETIC 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27789-911
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27789-911-0260 g in 1 BOTTLE; Type 0: Not a Combination Product04/04/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/04/2012
    Labeler - PHI, Inc (611203035)
    Registrant - Filltech USA, LLC (965596435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(27789-911)

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