POVIDONE IODINE- povidone iodine 10% liquid

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine 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

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Purpose

Antiseptic

Use

First aid antiseptic to prevent infection in minor cuts and burns.

Warnings

For External Use Only

Ask a doctor before use if you have

• deep punture wounds
• animal bites
• serious burns

Stop use and consult a doctor if

• the condition persists or gets worse
• irritation and redness develop and persits for more than 72 hours

When using this product do not

• use in eyes
• use on individuals who are allergic or sensitive to iodine or use for longer thn 1 week unless directed by a doctor
• apply over large areas of the body

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or 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 badaged, let it dry first.

Other information

store at room temperature, 20-25C (68-77F)

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

Sunmark Label

8 fl oz

16 fl oz

Good Neighbor Label

Leader Label

Quality Choice Label

Selecy Brand Label

Publix Label

Prenier Value Label

Fred's Label

DDM Label

Rite Aid Label

CVS Label

Vida MIaa Label

HEB Label

Health Mart Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine 10% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0395-9123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0395-9123-98	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017
2	NDC: 0395-9123-16	473 mL in 1 BOTTLE, PLASTIC; 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	01/01/2008

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(0395-9123) , analysis(0395-9123) , pack(0395-9123) , label(0395-9123)