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Freds Povidone Iodine

Dosage form: liquid
Ingredients: POVIDONE-IODINE 100mg in 1mL
Labeler: Fred's, Inc.
NDC Code: 55315-325

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-325
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
NONOXYNOL-9 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:55315-325-98237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2008
Labeler - Fred's, Inc. (005866116)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884manufacture(55315-325), analysis(55315-325), pack(55315-325), label(55315-325)

 
Fred's, Inc.

Medically reviewed on Nov 14, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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