FDA.reportPublic FDA data

Bernard Jensen PovDine Gargle Solution

Manufacturer
Great North, LLC, dba Bernard Jensen Products
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:52

Label at a glance#

ProductBernard Jensens PovDine
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Storage and handling

Other information store at room temperature may stain clothing, dentures and braces avoid contact with jewelry, especially silver

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (before dilution)

Povidone-iodine 1%

OTC - PURPOSE SECTION

Purpose

Antiseptic gargle

INDICATIONS & USAGE SECTION

Use

first aid to help prevent the risk of infection in minor cuts and scrapes caused by dental procedures or accidental injury

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use for more than 7 days unless directed by a dentist or doctor

OTC - STOP USE SECTION

Stop use and ask a dentist or doctor if

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for gargling is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years and older:

  • dilute 1 tablespoon (15 ml) of product with equal amount of water
  • rinse and gargle for 30 seconds, then spit out. Do not swallow solution or rinse mouth afterward
  • use up to four times daily for no more than 7 days

Children under 12 years: do not use

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature
  • may stain clothing, dentures and braces
  • avoid contact with jewelry, especially silver

INACTIVE INGREDIENT SECTION

Inactive ingredients. glycerin, menthol, ethyl alcohol (6%), sodium hydroxide, purified water

OTC - QUESTIONS SECTION

Questions? (800) 755-4027

SPL UNCLASSIFIED SECTION

Dilute with equal parts water before use.

Sealed with a tamper-evident cap for your protection. If ring band is detached from cap or missing, do not use.

Distributed by:

Bernard Jensen Products

Chula Vista, CA 91911

www.bernardj.com

Made in Mexico

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bernard Jensen's

PovDine™

GARGLE SOLUTION

ORAL ANTISEPTIC

1% Povidone-Iodine Concentrated Solution

Mint Flavor

1 fl oz (30 ml)

Povidine 1Povidine 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238272povidone-iodine 1 % Oral RinsePSN1
238272povidone-iodine 10 MG/ML MouthwashSCD1
238272povidone-iodine 1 % Oral RinseSY1

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79994-001-012022-07-29C16284748780-1e4f33bdf-a6ac-d8a0-e053-dadaa90a6e4eBernard Jensen PovDine Gargle Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79994-001-01Bernard Jensens PovDine30 mL in 1 BOTTLESOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79994-001BERNARD JENSENS POVDINE (POVIDONE IODINE) SOLUTION [GREAT NORTH, LLC, DBA BERNARD JENSEN PRODUCTS]1Legacy NDC, 1 package rows20210114_b8b9f2d3-1b08-4c1e-e053-2995a90aa250.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79994-00179994-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b8b9f2d3-1b09-4c1e-e053-2995a90aa250b8b9f2d3-1b08-4c1e-e053-2995a90aa2502021-01-12WarningsExact identifier
spl id: b8b9f2d3-1b09-4c1e-e053-2995a90aa250
spl set id: b8b9f2d3-1b08-4c1e-e053-2995a90aa250

Reported adverse events (FAERS/openFDA)#

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