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First Aid Antiseptic

Rite Aid 050.002/050AE Povidone Iodine Solution

Approved
Approval ID

2f8abb6f-460f-47bf-811d-734126aa3f0b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Rite Aid

DUNS: 014578892

Products 1

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

POVIDONE-IODINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-9050
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
POVIDONE-IODINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (7)

C12-13 PARETH-9Inactive
Code: 9BXD858P37
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POVIDONE-IODINEActive
Quantity: 10 mg in 1 mL
Code: 85H0HZU99M
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

principal display panel

Compare to Betadine ®Antiseptic*

FREE FROM

PARABEN FREE

POVIDONE-IODINE

TOPICAL SOLUTION, 10%

FIRST AID ANTISEPTIC

Helps prevent the risk of infections in minor cuts, scrapes & burns

8 FL OZ (237 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 8/12/2025

Adverse Reactions

DISTRIBUTED BY:

RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION GUARANTEE

If you're not satisfied, we'll happily refund your money.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

  • 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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/12/2025

Disclaimer

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/12/2025

Do not use

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 8/12/2025

Ask a doctor before use

in case of deep or puncture counds, animal bites, or serious burns

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/12/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/12/2025

Keep out of reach of children.

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

inactive ingredents

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

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First Aid Antiseptic - FDA Drug Approval Details