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Drug Facts - Saninta 10% w/v Povidone-Iodine Solution

Manufacturer
Lernapharm
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:17

Label at a glance#

ProductSaninta 10% Povidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Dosage and administration

Clean the area. apply locally as needed

Storage and handling

1% titratable iodine not made with natural rubber latex for hospital or professional use only Store at room temperature between 59-86ºF (15 - 30ºC). Avoid freezing and excessive heat above 40ºC (104ºF).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 10% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Antiseptic skin preparation. Helps reduce bacteria that potentially can cause skin infection.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use

  • if allergic to iodine
  • in the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctorif

  • injuries are deep puncture wounds or serious burns
  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Avoid pooling beneath patient

OTHER SAFETY INFORMATION

Avoid pooling beneath patient

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the area.
  • apply locally as needed

Other Information

STORAGE AND HANDLING SECTION

  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • Store at room temperature between 59-86ºF (15 - 30ºC).
  • Avoid freezing and excessive heat above 40ºC (104ºF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerol, Nonoxynol-9, Purified Water USP, Sodium Hydroxide, Sodium Phosphate Dibasic

Questions or Comments?

OTC - QUESTIONS SECTION

Questions or Comments? Tel.: 1-866-322-4634, weekdays between 8:00 am and 4:00 pm EST

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 68356-601-01 / 68356-601-601-02 / 68356-601-03

Product # 601-01 / 601-02 / 601-03

Hold upright

[Tear here and pour]

[Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone-iodine solution]

[Tear open]

Saninta

Antiseptic Solution

10% w/v Povidone-Iodine Solution

10% Povidone-Iodine

[0.75 Fl. oz (22.5 mL)]

[0.5 Fl. oz (15 mL)]

Do Not Reuse

multiple-use cross-through logo

UPC Code

Manufactured by:

Lernapharm (LORIS) Inc.

2323 HALPERN, MONTREAL

QUEBEC, CANADA H4S 1S3

Made in Canada

LOT #: XXXX

EXP.: MM/YYYY

image of 68356-601-01 labelimage of 68356-601-01 label

image of 68356-601-02image of 68356-601-02

image of 68356-601-03 labelimage of 68356-601-03 label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN2
797730povidone-iodine 100 MG/ML Medicated PadSCD2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY2
797730povidone-iodine 10 % Medicated PadSY2
797730povidone-iodine 10 % Medicated SwabstickSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68356-601-01Saninta 10% Povidone-Iodine2.3 mL in 1 APPLICATORLIQUID2.32
68356-601-01Saninta 10% Povidone-Iodine3 in 1 POUCHLIQUID32
68356-601-02Saninta 10% Povidone-Iodine22.5 mL in 1 PACKETLIQUID22.52
68356-601-03Saninta 10% Povidone-Iodine15 mL in 1 PACKETLIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68356-601SANINTA 10% POVIDONE-IODINE (POVIDONE-IODINE SOLUTION) LIQUID [LERNAPHARM]2Current NDC, 4 package rows20241116_1275efa3-0602-2f17-e063-6394a90ac56e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68356-60168356-601-01, 68356-601-02, 68356-601-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
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
Saninta 10% Povidone-IodinePOVIDONE-IODINE SOLUTIONLernapharm1275efa3-0602-2f17-e063-6394a90ac56e2024-11-15WarningsExact identifier
ndc (package): 68356-601-03
ndc (package): 68356-601-02
ndc (package): 68356-601-01
ndc (product): 68356-601
ndc11 (package): 68356060101
ndc11 (package): 68356060102
ndc11 (package): 68356060103
spl id: 26edf53b-4ba3-a69b-e063-6294a90a1769
spl set id: 1275efa3-0602-2f17-e063-6394a90ac56e

Reported adverse events (FAERS/openFDA)#

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