BETADINE® Spray 5% Povidone-iodine

Manufacturer: Atlantis Consumer Healthcare, Inc.
Effective date: 2025-12-24
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-06-01 01:29:33

Label at a glance#

ProductBetadine

Active ingredientPOVIDONE-IODINE

Label structure13 sections

Indications and uses

First aidto help prevent infection in minor cuts scrapes burns

Dosage and administration

clean the affected area spray a small amount of the product on the area 1 to 3 timesa daily may be covered with sterile bandage if bandaged, let dry first

Storage and handling

store at25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do NotFreeze

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Povidone-iodine, 5%(0.5% available iodine)

Purpose

OTC - PURPOSE SECTION

First aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aidto help prevent infection in minor

cuts
scrapes
burns

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 ingredientsin this preparation

Ask a doctor before useif you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds
serious burns
animal bites

Stop use and ask a doctor if

OTC - STOP USE SECTION

the condition persists or gets worse
you need to use this product for more than 1 week

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centerright away.

Directions

DOSAGE & ADMINISTRATION SECTION

clean the affected area
spray a small amount of the product on the area 1 to 3 timesa daily
may be covered with sterile bandage
if bandaged, let dry first

Other information

STORAGE AND HANDLING SECTION

store at25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do NotFreeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine 3oz Spray
NDC: 67618-160-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
108204	BETADINE 5 % Topical Spray	PSN	11
238850	povidone-iodine 5 % Topical Spray	PSN	11
108204	povidone-iodine 50 MG/ML Topical Spray [Betadine]	SBD	11
238850	povidone-iodine 50 MG/ML Topical Spray	SCD	11
108204	Betadine 5 % Topical Spray	SY	11
108204	Betadine 50 MG/ML Topical Spray	SY	11
238850	povidone-iodine 5 % Topical Spray	SY	11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67618-160-03	Betadine	89 mL in 1 BOTTLE	SPRAY	89		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-160-03	ML - Milliliter	67618-160	665821c0-060c-4c30-90aa-10441eb66ef4	1	2016-02-04

Products#

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

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

Betadine
POVIDONE-IODINE
IODINE
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE
GLYCERIN
POLOXAMER 407
POTASSIUM IODATE
WATER
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67618-160	67618-160-03

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
Name	UNII	Kind
POVIDONE-IODINE	85H0HZU99M	ACTIM
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE	BWZ7K44R51	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POTASSIUM IODATE	I139E44NHL	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
043f3c0e-36f5-440a-81b7-6bf5c0b52020			f9939dca-cd07-3200-a95b-177a771585af	2025-12-24	Warnings	Exact identifier spl id: 043f3c0e-36f5-440a-81b7-6bf5c0b52020 spl set id: f9939dca-cd07-3200-a95b-177a771585af

Reported adverse events (FAERS/openFDA)#

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