Betadine

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:50:51

Label at a glance#

ProductBetadine Surgical Scrub
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Storage and handling

Other information store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F) store in original container

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts


Active ingredient

Povidone-iodine, 7.5%(0.75% available iodine)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

  • helps to reduce bacteria that potentially can cause skininfection
  • for handwashing to reduce bacteria on the skin
  • significantly reduces the number of microorganisms on thehands and forearms prior to surgery or patient care

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use this product

  • in the eyes

OTC - WHEN USING SECTION

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor

  • if irritation and redness develop
  • in rare instances of local irritation or sensitivity

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  1. Surgical hand scrub:
    • wet hands with water
    • spread about 5 cc (1 teaspoonful) of Scrub over both handsand forearms
    • without adding more water, scrub thoroughly for 2 1/2 to3 minutes
    • use a sponge if desired. Clean thoroughly under fingernails.
    • add a little water and develop copious suds. Rinse thoroughlyunder running water.
    • repeat the entire procedure using another 5 cc of Scrub
  2. Antiseptic hand wash:
    • wet hands with water and pour about 5 cc of Scrub on hands
    • rub hands vigorously together for at least 15 seconds, coveringall surfaces
    • rinse and dry with a disposable towel

STORAGE AND HANDLING SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

ammonium nonoxynol-4sulfate, nonoxynol-9, purified water, sodium hydroxide

SPL UNCLASSIFIED SECTION

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

304954-0A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Surgical Scrub
NDC 67618-151-17

NDC 67618-150-17
NDC 67618-150-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1149658BETADINE 7.5 % Medicated Liquid SoapPSN11
211747povidone-iodine 7.5 % Medicated Liquid SoapPSN11
1149658povidone-iodine 75 MG/ML Medicated Liquid Soap [Betadine]SBD11
211747povidone-iodine 75 MG/ML Medicated Liquid SoapSCD11
1149658Betadine 75 MG/ML Medicated Liquid SoapSY11
1149658Betadine Skin Cleanser 7.5 % Medicated Liquid SoapSY11
1149658Betadine Surgical Scrub 7.5 % Medicated Liquid SoapSY11
211747povidone-iodine 7.5 % Medicated Liquid SoapSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-151-01BetadineSurgical Scrub3780 mL in 1 BOTTLESOLUTION378011
67618-151-04BetadineSurgical Scrub118 mL in 1 BOTTLESOLUTION11811
67618-151-16BetadineSurgical Scrub473 mL in 1 BOTTLESOLUTION47311
67618-151-17BetadineSurgical Scrub1 in 1 CARTONSOLUTION111
67618-151-17BetadineSurgical Scrub473 mL in 1 BOTTLESOLUTION47311
67618-151-32BetadineSurgical Scrub946 mL in 1 BOTTLESOLUTION94611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-151BETADINE SURGICAL SCRUB (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]11Current NDC, Legacy NDC, 6 package rows20250108_1ad39e11-ea1e-44a4-8224-93f8135436c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-151-01ML - Milliliter67618-151a2eefddd-3b28-4a3b-bfd5-c9f865241eb612012-07-24
67618-151-04ML - Milliliter67618-151878df6d8-51c5-40e4-99fb-7af1bd81522712012-07-24
67618-151-16ML - Milliliter67618-151f96e02d7-14c0-4bc9-bee0-6918cf56f12e12012-07-24
67618-151-17ML - Milliliter67618-15146650e95-655b-48d8-a6e3-3c710971a77f12012-07-24
67618-151-32ML - Milliliter67618-151f5eb7cb8-17e2-43df-b367-21f5d019428f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
POVIDONE-IODINEACTIVE MOIETY85H0HZU99M1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-15167618-151-04, 67618-151-16, 67618-151-17, 67618-151-32, 67618-151-01

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates

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
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
ndc (package): 67618-151-04
ndc (package): 67618-151-32
ndc (package): 67618-151-17
ndc (package): 67618-151-01
ndc (package): 67618-151-16
ndc (product): 67618-151
ndc11 (package): 67618015101
ndc11 (package): 67618015116
ndc11 (package): 67618015132
ndc11 (package): 67618015117
ndc11 (package): 67618015104
spl id: 26bf0dc4-726a-4f00-a3f8-1672431c6899
spl set id: 1ad39e11-ea1e-44a4-8224-93f8135436c2

Reported adverse events (FAERS/openFDA)#

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