Available Formats

• Zcaine Fast Acting Anesthetic Gel

  
  

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• Drug Facts

  
  

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• Active Ingredients

  Lidocaine 4%
  

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• Purpose

  Topical Anesthetic
  

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• Uses:

  For the temporary relief of discomfort and pain associated with
  

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

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• 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
    

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• Keep out of reach of children

  
  

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• Directions

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

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• 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

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• Zcaine Fast Acting Anesthetic Gel 2oz/60g

  

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• INGREDIENTS AND APPEARANCE

  ZCAINE FAST ACTING ANESTHETIC  lidocaine gel

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27789-911 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g  in 100 g

  Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:27789-911-02 60 g in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2012

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/04/2012

  Labeler - PHI, Inc (611203035)

  Registrant - Filltech USA, LLC (965596435)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Filltech USA, LLC		926433855	manufacture(27789-911)

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