FDA.reportPublic FDA data

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

Manufacturer
LL Pharma | LL Pharma Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:30:33

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.: 1-833-336-6159

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 81351-004-01 / 81351-004-02

Product # 004-01 / 004-02

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]

[0.75 Fl.ox (22.5 mL)]

Latex cross-through logo

multiple-use cross-through logo

UPC Code

Manufactured by:

LL Pharma Inc.

5789 rue Cypihot, Saint-Laurent, Quebec H4S 1R3

Made in Canada

www.llpharmainc.com

LOT #: XXXX

EXP.: MM/YYYY

image of 81351-004-01 swabstick labelimage of 81351-004-01 swabstick label

image of 81351-004-01 22.5 mL packet labelimage of 81351-004-01 22.5 mL packet label

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
81351-004-01Saninta 10% Povidone-Iodine2.3 mL in 1 APPLICATORLIQUID2.36
81351-004-01Saninta 10% Povidone-Iodine3 in 1 POUCHLIQUID36
81351-004-02Saninta 10% Povidone-Iodine22.5 mL in 1 PACKETLIQUID22.56

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
81351-00481351-004-01, 81351-004-02

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 SOLUTIONLL Pharmabd344007-895e-30d6-e053-2a95a90a019d2025-12-31WarningsExact identifier
ndc (package): 81351-004-01
ndc (package): 81351-004-02
ndc (product): 81351-004
ndc11 (package): 81351000401
ndc11 (package): 81351000402
spl id: 47446355-315f-6485-e063-6294a90a0377
spl set id: bd344007-895e-30d6-e053-2a95a90a019d

Reported adverse events (FAERS/openFDA)#

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