FDA.reportPublic FDA data

1108 Povidone Iodine Prep Pad NDC 67777-002-01

Manufacturer
Dynarex Corporation
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:54:19

Label at a glance#

ProductPovidone Iodine Prep Pad
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

Tear at notch Remove prep pad Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage If bandaged, let dry first Use only once

Storage and handling

Store at room temperature 15º-30ºC (59º-86ºF) Flammable. Keep away from fire or flame

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 10% w/v (9.85% w/w)

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For External Use Only

Do not use

WARNINGS SECTION

• In the eyes or over large areas of the body

• Longer than one week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• Deep or puncture wounds

• Animal bites

• Serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Condition persists or gets worse

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Tear at notch
  • Remove prep pad
  • Apply a small amount of this product on the area 1 to 3 times daily.
  • May be covered with a sterile bandage
  • If bandaged, let dry first
  • Use only once

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 15º-30ºC (59º-86ºF)
  • Flammable. Keep away from fire or flame

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Anhydrous Citric Acid, Glycerin, Polysorbate 80, Sodium Citrate USP, Sodium Phosphate Dibasic, Water

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Povidone-Iodine Prep PadsPovidone-Iodine Prep Pads

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1108 BX MASTER1108 BX MASTERPovidon Iodine Prep Pad

Label 1108UB-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1108UB-10_BX_MASTER1108UB-10_BX_MASTER1108UB-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN8
797730povidone-iodine 100 MG/ML Medicated PadSCD8
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY8
797730povidone-iodine 10 % Medicated PadSY8
797730povidone-iodine 10 % Medicated SwabstickSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784110820GTIN-13: 0616784110820
EAN-13: 0616784110820
GTIN-12: 616784110820
UPC-A: 616784110820
GTIN storage (14 digits): 00616784110820		1108 BX MASTER.jpg
BarcodeEAN-130840117327672GTIN-13: 0840117327672
EAN-13: 0840117327672
GTIN-12: 840117327672
UPC-A: 840117327672
GTIN storage (14 digits): 00840117327672		1108UB-10_BX_MASTER_R231110-1.jpg
QR code linkQR Codedynarex.com/symbols.php1108 BX MASTER.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-002-01Povidone Iodine Prep Pad10 in 1 CASESWAB108
67777-002-02Povidone Iodine Prep Pad100 in 1 BOXSWAB1008
67777-002-02Povidone Iodine Prep Pad0.3 g in 1 PACKETSWAB0.38
67777-002-03Povidone Iodine Prep Pad100 in 1 CASESWAB1008
67777-002-04Povidone Iodine Prep Pad10 in 1 BOXSWAB108
67777-002-04Povidone Iodine Prep Pad0.3 g in 1 PACKETSWAB0.38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-002-01EA - Each67777-0023fbdbb6c-3fd2-4fc5-8188-a71746cab8f512025-08-11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-00267777-002-04, 67777-002-03, 67777-002-02, 67777-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM CITRATE1Q73Q2JULRIACT
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
ndc (package): 67777-002-02
ndc (package): 67777-002-03
ndc (package): 67777-002-01
ndc (package): 67777-002-04
ndc (product): 67777-002
ndc11 (package): 67777000201
ndc11 (package): 67777000203
ndc11 (package): 67777000202
ndc11 (package): 67777000204
spl id: 4ddd1f85-ed0e-bdff-e063-6394a90a4da3
spl set id: 81b475e8-8da4-7b15-e053-2991aa0a6629

Reported adverse events (FAERS/openFDA)#

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