Label: IODINE- iodine alcoholic solution
- NDC Code(s): 16638-166-38
- Packager: Borisovskiy Zavod Medicinskikh Preparatov JSC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 26, 2015
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- Active ingredients
Iodine - 0.5 g, Potassium Iodide - 0.2 gClose
Bactericidial - antisepticClose
For inflammatory and infectious diseases of skin, cuts, minor injuries, wounds, myositis, neuraldia; for disinfection of the operational field.Close
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.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control center immediately.Close
Apply to affected areas as needed or as directed by physician.Close
- Other information
Keep in a dark place at temperature below 25 oC.Close
- Inactive ingredients
Ethanol, Purified WaterClose
- INGREDIENTS AND APPEARANCE
iodine alcoholic solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16638-166 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 0.5 g in 10 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 0.2 g in 10 mL Inactive Ingredients Ingredient Name Strength ETHANOL, 2-(BIS(2-METHYLPROPYL)PHENOXY)- (UNII: AUK0O5KW1Y) 10 mL in 10 mL WATER (UNII: 059QF0KO0R) 10 mL in 10 mL Product Characteristics Color brown (Transparent red-brown liquid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16638-166-38 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/20/1999 Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593) Establishment Name Address ID/FEI Business Operations Borisovskiy Zavod Medicinskikh Preparatov JSC 628149593 manufacture(16638-166)