IODINE TINCTURE MILD- iodine and sodium iodide and alcohol liquid

Iodine Tincture Mild by

Drug Labeling and Warnings

Iodine Tincture Mild by is a Otc medication manufactured, distributed, or labeled by Humco Holding Group, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Iodine 2%

Purpose

First Aid Antiseptic

Active ingredient

Sodium Iodide 2.4%

Purpose

First Aid Antiseptic

Active ingredient

Alcohol 47%

Purpose

First Aid Antiseptic

Indications

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
  
• Flammable: Keep away from sparks heat and flame

Stop use and consult doctor if

• the condition persists or gets worse, or if using for longer than one 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 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 on the area 1 to 3 times daily
  
• may be covered with sterile bandage
  
• if bandaged let dry first

Other information

• will stain skin and clothing

Inactive ingredient

Purified Water

Old Label

New Label

INGREDIENTS AND APPEARANCE

IODINE TINCTURE MILD 
iodine and sodium iodide and alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-1213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	20 mg  in 1 mL
SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	20.4 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	470 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-1213-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2017
2	NDC: 0395-1213-91	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/14/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/1979

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(0395-1213) , analysis(0395-1213) , pack(0395-1213) , label(0395-1213)