Version
v4
HUMCO 1 Percent Iodine — v4
HUMCO 1 Percent Iodine
5 Views
Effective date
September 22, 2025
Original packager
Yes
Sections captured
12
Identifiers
- Document ID
- 3f638681-b7bc-0ef0-e063-6294a90a4512
- Set ID
- 139efeef-be20-4362-a5ba-158b8fa40e0d
- Application numbers
- M003
- Product NDCs
- 0395-1211
- Package NDCs
- 0395-1211-16
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- HUMCO 1 Percent Iodine
- Generic names
- ISOPROPYL ALCOHOL
- Manufacturer names
- Humco Holding Group, Inc.
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- ISOPROPYL ALCOHOL
- Routes
- TOPICAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- 808520
- UNII
- ND2M416302
- UPC
- 0303951211168
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active Ingredient Isopropyl Alcohol 70%
Do Not Use (1)
Sequence 1
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.
Dosage And Administration (1)
Sequence 1
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.
Inactive Ingredient (1)
Sequence 1
Inactive Ingredient Iodine 1%, Potassium iodide, Purified water.
Indications And Usage (1)
Sequence 1
Indications Preoperative skin preparation. Helps to reduce skin bacteria that potentially can cause skin infection.
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Other Safety Information (1)
Sequence 1
Other Information Will stain skin and clothing. Store at room temperature.
Package Label Principal Display Panel (1)
Sequence 1
PRINCIPAL DISPLAY PANEL 1 Iodine Label capture
Purpose (1)
Sequence 1
Purpose Topical antiseptic
Spl Product Data Elements (1)
Sequence 1
HUMCO 1 Percent Iodine Isopropyl Alcohol IODINE POTASSIUM IODIDE WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL
Spl Unclassified Section (1)
Sequence 1
HUMCO 1% Iodine Tincture Drug Facts
Warnings (1)
Sequence 1
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.
OpenFDA raw payload
{'application_number': ['M003'],
'brand_name': ['HUMCO 1 Percent Iodine'],
'generic_name': ['ISOPROPYL ALCOHOL'],
'is_original_packager': [True],
'manufacturer_name': ['Humco Holding Group, Inc.'],
'package_ndc': ['0395-1211-16'],
'product_ndc': ['0395-1211'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['TOPICAL'],
'rxcui': ['808520'],
'spl_id': ['3f638681-b7bc-0ef0-e063-6294a90a4512'],
'spl_set_id': ['139efeef-be20-4362-a5ba-158b8fa40e0d'],
'substance_name': ['ISOPROPYL ALCOHOL'],
'unii': ['ND2M416302'],
'upc': ['0303951211168']}