Label: HUMCO 1 PERCENT IODINE- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0395-1211-16 - Packager: Humco Holding Group, Inc.
- 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.
Drug Label Information
Updated December 11, 2018
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Indications
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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.
- Directions
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- Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HUMCO 1 PERCENT IODINE
isopropyl alcohol liquidProduct 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)