TOP CARE DECOLORIZED IODINE- ethyl alcohol liquid

Top Care Decolorized Iodine by

Drug Labeling and Warnings

Top Care Decolorized Iodine by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Alcohol 45 % denatured with ammonia, Ammonium and Potassium Iodides.

Purpose

Antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Ask a doctor before use if you have

deep or puncture wounds, animal bites, serious burns.

Stop use and ask a doctor if:

The condition persists or gets worse, or if using this product for longer than 1 week.

When using this product:

Do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids. Do not apply over large areas of the body.

Keep out of the reach of children.

In case of acidental ingestion give milk, then give a starch solution made by mixing two tablespoonfools of cornstarch or flour to a pint of water. contact a poison Control Center immediately.

Directions

Clean the affected area. Aply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let it dry first.

Inactive Ingredient:

Purified Water

Pther Information:

Will stain skin and clothing

Label

INGREDIENTS AND APPEARANCE

TOP CARE DECOLORIZED IODINE 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.45 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
IODINE (UNII: 9679TC07X4)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-207-92	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/25/1998

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(36800-207) , analysis(36800-207) , pack(36800-207) , label(36800-207)