GYNO-BETADINE

Manufacturer
OASIS TRADING
Effective date
2019-03-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:55

Label at a glance#

ProductGYNO-BETADINE
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

POVIDONE-IODINE

OTC - PURPOSE SECTION

Local treatment in the following cases: Candidate vaginitis, trichomonas vaginitis, non-specific and mixed infection, preoperative pre-operative treatment of obstetrics and gynecology, local cleaning and release

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Put 200 mg deep into the vagina once a day. It is advisable to insert it in the evening before bedtime. To increase or decrease appropriately according to age and symptoms.

WARNINGS SECTION

Do not use
in the eyes
as a first aid antiseptic longer than one week
on individuals who are allergic or sensitive to iodine
over large areas of the body
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

POLYETHYLENE GLYCOL 1540

DOSAGE & ADMINISTRATION SECTION

For vaginal use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
72689-0042-12021-01-29C16284748780-1ba0f9c33-4e05-a910-e053-dadaa90a0b8584a633dc-bd52-0571-e053-2a91aa0a6df8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0042-1GYNO-BETADINE10 in 1 BLISTER PACKSUPPOSITORY101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0042GYNO-BETADINE (POVIDONE IODINE) SUPPOSITORY [OASIS TRADING]1Legacy NDC, 1 package rows20190322_84a633dc-bd52-0571-e053-2a91aa0a6df8.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72689-004272689-0042-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
POVIDONE-IODINE85H0HZU99MACTIM

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
84a6a29c-1374-f375-e053-2991aa0a1c1484a633dc-bd52-0571-e053-2a91aa0a6df82019-03-21WarningsExact identifier
spl id: 84a6a29c-1374-f375-e053-2991aa0a1c14
spl set id: 84a633dc-bd52-0571-e053-2a91aa0a6df8

Reported adverse events (FAERS/openFDA)#

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