FREDS POVIDONE IODINE- povidone iodine 10% liquid
Fred's, 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.

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Fred's Povidone Iodine

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

FREDS POVIDONE IODINE
povidone iodine 10% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-325
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55315-325-98	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/01/2008	12/31/2020

Labeler - Fred's, Inc. (005866116)

Registrant - Humco Holding Group, Inc. (825672884)

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

Revised: 6/2020

Document Id: a7afbe7b-c712-b8d7-e053-2a95a90a15b2

Set id: 5df4c41e-c1b5-e1e1-e053-2a91aa0a1a69

Version: 2

Effective Time: 20200609

Fred's, Inc.