LEADER MILD IODINE- iodine,sodium iodide, alcohol tincture
Cardinal Health

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.

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LEADER 2% Mild Iodine Tincture USP

Drug Facts

Active Ingredients

Iodine 2%
Sodium Iodide 2.4%
Alcohol 47%

Purpose

Antiseptic

Uses:

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 reach of children.

In case of accidental ingestion. Give milk, then give 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 the affected area.

Apply a small amount to th affected area 1 to 3 times daily. May be covered with a sterile bandage.

If bandaged, let dry first.

Other Information:

Will stain skin and clothing.

Inactive Ingredients:

Purified Water.

Distributed by: Cardinal Health Dublin, Ohio 43017 1-800-200-6313 www.myleader.com

All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

LEADER 2% Mild Iodine Tincture USP 1oz/30ml (37205-022-10)

IodineTincture

LEADER MILD IODINE
iodine,sodium iodide, alcohol tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	2 mg in 100 mL
SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	2.4 mg in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	47 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-022-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/15/2012	07/31/2021

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(37205-022) , analysis(37205-022) , pack(37205-022)

Revised: 7/2022

Document Id: e428c523-aa89-8d4e-e053-2995a90aead6

Set id: f79ec553-4b96-46f7-b620-af9ac9673c41

Version: 4

Effective Time: 20220719

Cardinal Health