FDA.reportPublic FDA data

Signature Select 050.002/050AE Povidone-Iodine Solution, 10%

Manufacturer
Better Living Brands, LLC | Nice-Pak Products, LLC
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:46:54

Label at a glance#

ProductFirst Aid Antiseptic
Active ingredientPOVIDONE-IODINE
Label structure15 sections

Indications and uses

first aid to help prevent the risk of infection in: minor cuts  scrapes  burns

Dosage and administration

clean the affected area 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

Storage and handling

store between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine, 10% (1% available iodine)

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent the risk of infection in:

  • minor cuts 
  • scrapes 
  • burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use

OTC - ASK DOCTOR SECTION

in case of deep or puncture wounds, animal bites, or 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • 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

Other information

STORAGE AND HANDLING SECTION

  • store between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-593-0593

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Betadine ®Antiseptic 10% Povidone-Iodine First Aid Antiseptic.

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

‡1-888-723-3929

LOVE IT OR IT'S ON US‡

smartlabel

Scan here for more information

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Betadine ®10% Povidone-Iodine Active Ingredient*

NDC 21130-891-34

Signature SELECT™

POVIDONE-IODINE SOLUTION, 10%

FIRST AID ANTISEPTIC

Helps prevent infection in minor cuts, scrapes, and burns

8 FL OZ (237 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN3
312564povidone-iodine 100 MG/ML Topical SolutionSCD3
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeQR Code0mm01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-891-34First Aid Antiseptic236 mL in 1 BOTTLE, PLASTICSOLUTION2363

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
21130-89121130-891-34

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
C12-13 PARETH-99BXD858P37IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
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
First Aid AntisepticPOVIDONE-IODINEBetter Living Brands, LLC3ce6e6af-b513-ed9f-e063-6394a90a4ce72026-02-23Warnings, Adverse reactionsExact identifier
ndc (package): 21130-891-34
ndc (product): 21130-891
ndc11 (package): 21130089134
spl id: 4b80d98d-980c-e2a3-e063-6394a90ac037
spl set id: 3ce6e6af-b513-ed9f-e063-6394a90a4ce7

Reported adverse events (FAERS/openFDA)#

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