BETADINE® Dry Powder Spray 5%Povidone-iodine

Manufacturer: Atlantis Consumer Healthcare, Inc.
Effective date: 2024-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:49:34

Label at a glance#

ProductBetadine Dry Powder

Active ingredientPOVIDONE-IODINE

Label structure8 sections

Dosage and administration

Clean the affected area SHAKE WELL BEFORE USE Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily May be covered with a sterile bandage

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

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

Purpose

OTC - PURPOSE SECTION

First aidantiseptic

Uses

INDICATIONS & USAGE SECTION

First aidto help prevent infection in minor

cuts
scrapes
burns

Warnings For external use only

WARNINGS SECTION

Extremely Flammable Do not use near heat, flame or while smoking. Do notpuncture or incinerate. Contents under pressure. Do not store at temperaturesabove 120⁰F. Intentional misuse by deliberately concentrating andinhaling the contents can be harmful or fatal

Do not use

OTC - DO NOT USE SECTION

in or near eyes
over large areas of the body
if you are allergic to povidone-iodine or any other ingredientsin this preparation

When using this product

OTC - WHEN USING SECTION

do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor.

Ask a doctor before use if 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 reachof children.
If swallowed, get medicalhelp or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area
SHAKE WELL BEFORE USE
Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily
May be covered with a sterile bandage

Other information

STORAGE AND HANDLING SECTION

store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Isobutane,isopropyl myristate, pentrane, propane

SPL UNCLASSIFIED SECTION

Dist. by: AvrioHealth L.P. Stamford, CT 06901-3431
305653-0A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BetadineDry Powder Spray
NDC: 67618-165-01

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-165	BETADINE DRY POWDER (POVIDONE-IODINE) AEROSOL, SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]	6	Legacy NDC	20250101_1888546e-893e-132d-72b4-d138e71a2a8c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-165-01	GM - Gram	67618-165	ae9cb57c-8209-4316-8c98-f7c30c60e7be	1	2021-03-02

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Betadine Dry Powder
POVIDONE-IODINE
IODINE
ISOBUTANE
ISOPROPYL MYRISTATE
PROPANE
METHOXYFLURANE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67618-165	67618-165-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POVIDONE-IODINE	85H0HZU99M	ACTIM
ISOBUTANE	BXR49TP611	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PROPANE	T75W9911L6	IACT
METHOXYFLURANE	30905R8O7B	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
8a9ef4cc-edbb-45e9-a188-764f53536cd4			1888546e-893e-132d-72b4-d138e71a2a8c	2024-12-26	Warnings	Exact identifier spl id: 8a9ef4cc-edbb-45e9-a188-764f53536cd4 spl set id: 1888546e-893e-132d-72b4-d138e71a2a8c

Reported adverse events (FAERS/openFDA)#

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