Available Formats

• SPL UNCLASSIFIED SECTION

  Drug Facts

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• Active ingredient

  Ethyl Alcohol 48%

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• Purpose

  First Aid Antiseptic                        

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• Use

  first aid to help prevent infection in minor cuts, scrapes and burns.

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• Warnings

  For external use only

  Flammable, keep away from fire or flame

  When using this product 

  do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

  Stop use and consult doctor if the

  condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

  Keep out of reach of children.

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

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• Directions

  • Clean the affected area.
    
  • apply a small amount on the area 1 to 3 times daily.
    
  • may be covered with sterile bandage.
    
  • if bandaged, let dry first.

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• Other information 

  store at room temperature

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• Inactive ingredients

  ammonium hydroxide, iodine, potassium iodide, and purified water

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• PRINCIPAL DISPLAY PANEL

  NDC 37205-648-16
  Leader ®
  Decolorized Iodine
  Alcohol 48%
  FIRST AID ANTISEPTIC
  For External Use Only
  2 FL OZ (59 mL)

  

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• INGREDIENTS AND APPEARANCE

  DECOLORIZED IODINE  ethyl alcohol liquid

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-648 Route of Administration TOPICAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.45 mL  in 1 mL

  Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X)   IODINE (UNII: 9679TC07X4)   POTASSIUM IODIDE (UNII: 1C4QK22F9J)   WATER (UNII: 059QF0KO0R)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-648-16 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/06/2017

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/1979

  Labeler - Cardinal Health (097537435)

  Registrant - Humco Holding Group, Inc. (825672884)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Humco Holding Group, Inc.		825672884	analysis(37205-648) , manufacture(37205-648) , pack(37205-648) , label(37205-648)

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