DECOLORIZED IODINE- ethyl alcohol liquid 
Cardinal Health

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.

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Leader Decolorized Iodine

Drug Facts

Active ingredient

Ethyl Alcohol 48%

Purpose

First Aid Antiseptic                        

Use

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

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.

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.

Other information 

store at room temperature

Inactive ingredients

ammonium hydroxide, iodine, potassium iodide, and purified water

PRINCIPAL DISPLAY PANEL

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

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

DECOLORIZED IODINE 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-648
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL48 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
IODINE (UNII: 9679TC07X4)  
POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-648-1659 mL in 1 BOTTLE; Type 0: Not a Combination Product12/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/197903/31/2022
Labeler - Cardinal Health (097537435)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc.825672884analysis(37205-648) , manufacture(37205-648) , pack(37205-648) , label(37205-648)

Revised: 7/2022
 
Cardinal Health