MedPath

Iodine

Good Sense 088.000/088AA Iodine Tincture USP

Approved
Approval ID

3b424440-5bb7-4207-9884-1461a54fbe0b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Perrigo Direct, Inc.

DUNS: 076059836

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Iodine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-088
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Iodine
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
IODINEActive
Quantity: 20 mg in 1 mL
Code: 9679TC07X4
Classification: ACTIB
SODIUM IODIDEActive
Quantity: 20.4 mg in 1 mL
Code: F5WR8N145C
Classification: ACTIM
ALCOHOLActive
Quantity: 470 mg in 1 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/8/2025

Principal Display Panel

NDC 50804-088-10

GoodSense ®

Iodine

Tincture U.S.P.

First Aid Antiseptic

For external use only

CAUTION: POISON

1 FL OZ (30 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/8/2025

Use

First aid to help prevent skin infection in

  • minor cuts
  • scrapes
  • burns

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 7/8/2025

ADVERSE REACTION

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDriect.com 1-888-593-0593

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/8/2025

Active Ingredient

Iodine 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/8/2025

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 7/8/2025

Warnings

For external use only

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/8/2025

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/8/2025

When using this product

  • do not use in eyes or apply over large areas of the body
  • do not use longer than 1 week unless directed by a doctor

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/8/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/8/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/8/2025

Directions

  • clean the affected area
  • apply a small amount on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/8/2025

Other information

product will stain skin and clothing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/8/2025

Inactive ingredients

alcohol (47% v/v), purified water, sodium iodide

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