HUMCO 1 PERCENT IODINE- isopropyl alcohol liquid

HUMCO 1 Percent Iodine by

Drug Labeling and Warnings

HUMCO 1 Percent Iodine by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HUMCO 1% Iodine Tincture

Drug Facts

Active Ingredient

Isopropyl Alcohol 70%

Purpose

Topical antiseptic

Indications

Preoperative skin preparation. Helps to reduce skin bacteria that potentially can cause skin infection.

Warnings:

Flammable: Keep away from spark, heat or flame.

Do not use with electrocautery procedures.

For external use only.

Do not use

in the eyes  

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

IF ON SKIN: Wash with plenty of soap and water.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If skin irritation or rash occurs of if eye irritation persists, get medical advice/attention. Take off contaminated clothing and wash before reuse.

IN CASE OF FIRE: Use dry sand, dry chemical or alcohol resistant foam to extinguish. Store in well ventilated place. Keep cool. Dispose contents/container to an approved waste disposal plant.

Keep out of reach of children.

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

Directions

• Use only by trained personnel.
  
• Clean the affected area.
  
• Apply product to operative site prior to surgery.
  
• When this product dries remove immediately with 70% alcohol or as directed by a physician.

Other Information

Will stain skin and clothing. Store at room temperature.

Inactive Ingredient

Iodine 1%, Potassium iodide, Purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HUMCO 1 PERCENT IODINE 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-1211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
IODINE (UNII: 9679TC07X4)	10 mg  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-1211-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/08/2017

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(0395-1211) , pack(0395-1211) , analysis(0395-1211) , label(0395-1211)