FDA.reportPublic FDA data

Private Label Povidone Iodine Spray 5%

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:39

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure13 sections

Indications and uses

First aid to help prevent infection in minor cuts scrapes burns

Dosage and administration

Clean the affected area Spray a small amount of product on the area 1 to 3 times daily May be covered with a sterile bandage If bandaged, let dry first

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 5%

(0.5% available iodine)

Warnings

WARNINGS SECTION

For external use only.

Do not use:

OTC - DO NOT USE SECTION

  • In the eyes
  • Over large areas of the body
  • If you are allergic to povidone-iodine or any other ingredients in this preparation

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Serious burns
  • Animal bites

Stop and ask a doctor if:

OTC - STOP USE SECTION

  • The condition persists or gets worse
  • You need to use this product for more that 1 week

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 right away.

Other Information

OTHER SAFETY INFORMATION

Store at 25°C (77°F); Excursions permitted between 15-30°C (59-86°F). Do not freeze.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

citric acid, disodium phosphate, glycerin, poloxamer 407, potassium iodata, purified water, sodium hydroxide.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Spray a small amount of product on the area 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Purpose

OTC - PURPOSE SECTION

Antiseptic

SPL UNCLASSIFIED SECTION

Drug Facts

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Spray 12-30-22Betadine Spray 12-30-22Purdue Betadine Spray.jpgPurdue Betadine Spray.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238850povidone-iodine 5 % Topical SprayPSN4
238850povidone-iodine 50 MG/ML Topical SpraySCD4
238850povidone-iodine 5 % Topical SpraySY4

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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9129-93Povidone Iodine89 mL in 1 CONTAINERLIQUID894

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9129POVIDONE IODINE (POVIDONE-IODINE SPRAY 5%) LIQUID [HUMCO HOLDING GROUP, INC.]4Current NDC, Legacy NDC, 1 package rows20231216_a7bb80c4-bbc0-21ea-e053-2995a90a52c1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91290395-9129-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM IODATEI139E44NHLIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM HYDROXIDE55X04QC32IIACT
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
Povidone IodinePOVIDONE-IODINE SPRAY 5%Humco Holding Group, Inc.a7bb80c4-bbc0-21ea-e053-2995a90a52c12023-12-15WarningsExact identifier
ndc (package): 0395-9129-93
ndc (product): 0395-9129
ndc11 (package): 00395912993
spl id: 0c9368f8-3986-07dd-e063-6394a90ac66a
spl set id: a7bb80c4-bbc0-21ea-e053-2995a90a52c1

Reported adverse events (FAERS/openFDA)#

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