IODINE- iodine alcoholic solution 
Borisovskiy Zavod Medicinskikh Preparatov JSC

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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Drug facts

Active ingredients

Iodine - 0.5 g, Potassium Iodide - 0.2 g

Purpose

Bactericidial - antiseptic

Uses

For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.

Warnings

For external use only.

Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.

Directions

Apply to affected areas as needed or as directed by physician.

Other information

Keep in a dark place at temperature below 25 oC.

Inactive ingredients

Ethanol, Purified Water

image of vial labelimage of group label 1image of group label 2

IODINE 
iodine alcoholic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16638-166
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.5 g  in 10 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.2 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)- (UNII: AUK0O5KW1Y) 10 mL  in 10 mL
WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
Product Characteristics
Colorbrown (Transparent red-brown liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16638-166-3810 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/20/1999
Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593)
Establishment
NameAddressID/FEIBusiness Operations
Borisovskiy Zavod Medicinskikh Preparatov JSC628149593manufacture(16638-166)

Revised: 11/2015
Document Id: 256e7111-d07a-576e-e054-00144ff88e88
Set id: dd1996bf-d7b4-4737-97fa-d98dda09e5c6
Version: 2
Effective Time: 20151126
 
Borisovskiy Zavod Medicinskikh Preparatov JSC