FDA.reportPublic FDA data

Betadine Surgical Scrub

Manufacturer
Atlantis Consumer Healthcare Inc
Effective date
2025-12-29
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:45:41

Label at a glance#

ProductBetadine Surgical Scrub
Active ingredientPovidone-Iodine
Label structure13 sections

Indications and uses

for preparation of the skin prior to surgery  helps to reduce bacteria that potentially can cause skin infection

Dosage and administration

after the surgical area is clipped, wet it with water  apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes  rinse off using sterile gauze saturated with water  the area may then be painted with BETADINE Solution Veterinary and allowed to dry  for use on companion animals, including dogs, cats, and horses

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

VETERINARY INDICATIONS SECTION

  • for preparation of the skin prior to surgery 
  • helps to reduce bacteria that potentially can cause skin infection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • on food-producing animals

When using this product

OTC - WHEN USING SECTION

  • do not heat prior to application
  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid "pooling" beneath the animal

Stop use and ask a veterinarian

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DirectionsPre-operative skin preparation:

DOSAGE & ADMINISTRATION SECTION

  • after the surgical area is clipped, wet it with water 
  • apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes 
  • rinse off using sterile gauze saturated with water 
  • the area may then be painted with BETADINE Solution Veterinary and allowed to dry 
  • for use on companion animals, including dogs, cats, and horses

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-833-288-2684

©2025 Atlantis Consumer Healthcare Inc.
Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

External Use Only       NDC 67618-154-16

For Professional Veterinary Use Only

BETADINE®
surgical scrub
Povidone-iodine, 7.5%

ANTISEPTIC
SUDSING
SKIN
CLEANSER

A Microbicidal
Cleanser

■ For pre-operative prepping of skin.
■ For use on companion animals, including dogs, cats, and horses.

Dist. by:
Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
www.betadine.com

16 fl oz (1 pt)
(473 ml)

401516BTLLBLA
304970-0B

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1149658BETADINE 7.5 % Medicated Liquid SoapPSN2
211747povidone-iodine 7.5 % Medicated Liquid SoapPSN2
1149658povidone-iodine 75 MG/ML Medicated Liquid Soap [Betadine]SBD2
211747povidone-iodine 75 MG/ML Medicated Liquid SoapSCD2
1149658Betadine 75 MG/ML Medicated Liquid SoapSY2
1149658Betadine Skin Cleanser 7.5 % Medicated Liquid SoapSY2
1149658Betadine Surgical Scrub 7.5 % Medicated Liquid SoapSY2
211747povidone-iodine 7.5 % Medicated Liquid SoapSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130367618154168GTIN-13: 0367618154168
EAN-13: 0367618154168
GTIN-12: 367618154168
UPC-A: 367618154168
GTIN storage (14 digits): 00367618154168		label.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-154-01Betadine Surgical Scrub3780 mL in 1 BOTTLESOLUTION37802
67618-154-16Betadine Surgical Scrub473 mL in 1 BOTTLESOLUTION4732

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
67618-15467618-154-16, 67618-154-01

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
NameUNIIKind
Povidone-Iodine85H0HZU99MACTIM
Ammonium Nonoxynol-4 Sulfate9HIA70O4J0IACT
Nonoxynol-948Q180SH9TIACT
Water059QF0KO0RIACT
Sodium Hydroxide55X04QC32IIACT

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 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Topical AntisepticPOVIDONE-IODINEMedline Industries, LPc9036a83-22f5-4a09-b01c-7093d4192c192026-08-28WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsName fallback
generic name: POVIDONE-IODINE
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsName fallback
generic name: POVIDONE-IODINE
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCff19ea2f-d6a0-442f-8f23-d559fc13c5492026-07-14WarningsName fallback
generic name: POVIDONE-IODINE
MedlinePOVIDONE-IODINEMedline Industries, LP1d731a44-f16e-c249-e063-6294a90a39b82026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Scrub SolutionPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdefa7f9f6-ae02-4104-bb9e-16e1ffd2be7a2026-06-17WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsName fallback
generic name: POVIDONE-IODINE
Maokang Povidone-Iodine Paint Solution AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd48f81109-3791-46ef-8992-d53b677a51b62026-06-02WarningsName fallback
generic name: POVIDONE-IODINE
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsName fallback
generic name: POVIDONE-IODINE
Lightning X Iodine Prep PadsPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd.5136a99b-ef40-937e-e063-6394a90a0a952026-05-07WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsName fallback
generic name: POVIDONE-IODINE

Reported adverse events (FAERS/openFDA)#

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