FDA.reportPublic FDA data

Freds Povidone Iodine

Manufacturer
Fred's, Inc. | Humco Holding Group, Inc.
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:27:14

Label at a glance#

ProductFreds Povidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure13 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Use Only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep punture wounds
  • animal bites
  • serious burns

Stop use and consult a doctor if

OTC - STOP USE SECTION

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

When using this product do not

OTC - WHEN USING SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-32555315-325-98

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a7afbe7b-c712-b8d7-e053-2a95a90a15b25df4c41e-c1b5-e1e1-e053-2a91aa0a1a692020-06-09WarningsExact identifier
spl id: a7afbe7b-c712-b8d7-e053-2a95a90a15b2
spl set id: 5df4c41e-c1b5-e1e1-e053-2a91aa0a1a69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.