HUMCO STRONG IODINE TINCTURE- iodine tincture liquid
Humo Holding Group, Inc.

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.

----------

Humco Strong Iodine Tincture

Drug Facts

Active Ingredients

Iodine 7%

Potassium Iodide 5%

alcohl 85%

Purpose

Antiseptic

Uses

To prevent infection in mior cuts, scrapes, and burns.

Warnings

For external use only

Ask a doctor if you have:

deep or puncture wounds

animal bites

serious burns.

Stop use and consult a doctor if:

The condition persists or gets worse, or if using for longer than once a week.

When using this product:

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

do not apply over large areas of the body.

Keep out of reach of children

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

Directions

Clean affacted area

Apply a small amount on the area 1 to 3 times daily.

May be covered with sterile bandage.

If bandaged, let it dry first.

Inactive Ingredient

Purified water

Principal Display Panel

image description

Label

HUMCO STRONG IODINE TINCTURE
iodine tincture liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-1219
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	70 mg in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	50 mg in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	850 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-1219-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/09/2017	07/31/2021
2	NDC:0395-1219-91	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/09/2017	07/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/25/1998	07/31/2021

Labeler - Humo Holding Group, Inc. (825672884)

Registrant - Pharma Nobis, LLC (118564114)

Name	Address	ID/FEI	Business Operations
Establishment
Pharma Nobis, LLC		118564114	manufacture(0395-1219) , label(0395-1219) , analysis(0395-1219) , pack(0395-1219)

Revised: 3/2022

Document Id: da6bcd14-2286-e7df-e053-2995a90a4526

Set id: 5835e005-4721-4ec1-98e8-412aba4e19f0

Version: 4

Effective Time: 20220317

Humo Holding Group, Inc.