FREDS POVIDONE IODINE- povidone iodine 10% liquid

Freds Povidone Iodine by

Drug Labeling and Warnings

Freds Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Fred's, Inc., Humco Holding Group, Inc.. 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.

Label

INGREDIENTS AND APPEARANCE

FREDS POVIDONE IODINE 
povidone iodine 10% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-325
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: 55315-325-98	237 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 - Fred's, Inc. (005866116)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(55315-325) , analysis(55315-325) , pack(55315-325) , label(55315-325)