Drug Facts - Saninta 10% W/v Povidone-iodine Solution

Drug Facts - Saninta 10% W/v Povidone-iodine Solution
SPL v2
SPL
SPL Set ID 1275efa3-0602-2f17-e063-6394a90ac56e
Route
TOPICAL
Published
Effective Date 2024-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Water Glycerin Nonoxynol-9 Sodium Hydroxide Sodium Phosphate Dibasic Dihydrate Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-26
Description

Povidone-Iodine 10% w/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine 10% w/v

Use

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

Warnings

For external use only.

Directions
  • Clean the area.
  • apply locally as needed
Do Not Use

Do not use

  • if allergic to iodine
  • in the eyes
Active Ingredient

Povidone-Iodine 10% w/v

Other Information
  • 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

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

Questions Or Comments?

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

Stop Use and Ask A Doctor

Stop use and ask a doctor if

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

Avoid pooling beneath patient

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Structured Label Content

Use

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

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Clean the area.
  • apply locally as needed
Do Not Use (Do not use)

Do not use

  • if allergic to iodine
  • in the eyes
Active Ingredient

Povidone-Iodine 10% w/v

Other Information
  • 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 ingredients)

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

Questions Or Comments? (Questions or Comments?)

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if

  • injuries are deep puncture wounds or serious burns
  • redness, irritation, swelling or pain persists or increases
  • infection occurs
Avoid Pooling Beneath Patient (Avoid pooling beneath patient)

Avoid pooling beneath patient

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:24.979731 · Updated: 2026-03-14T23:05:07.358425