Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 7a1ba66a-e5be-415f-8aee-c132330836d4
Route
TOPICAL
Published
Effective Date 2022-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Sodium Phosphate, Dibasic Anhydrous Citric Acid Glycerin Nonoxynol-9 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-13 Until 2022-07-20
Description

Povidone Iodine 10% w/v

Medication Information

Warnings and Precautions

For External Use Only

Indications and Usage

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.

Dosage and Administration
  • Clean the area.

  • Apply product to the operative site prior to surgery.
  • Apply with friction for 30 seconds.
  • Do not blot or wipe away.

Description

Povidone Iodine 10% w/v

Section 42229-5
  • Do not use in the eyes.
  • Discontinue use if irritation and redness develop.

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Hold upright

Product # 119-XXU NDC: 68356-119-XX

Loris Povidone-Iodine [Solution]

[TEAR OPEN] [Tear here and pour]

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

[0.75 Fl. oz (22.5 mL)]

Antiseptic Solution

For hospital and professional use only

MANUFACTURED BY

LERNAPHARM (LORIS) INC.

2323 HALPERN, VILLE ST-LAURENT

QUEBEC, CANADA H4S 1S3

Section 53413-1

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

Section 55105-1

Antiseptic

Section 55106-9

Povidone Iodine 10% w/v

Structured Label Content

Indications and Usage (34067-9)

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.

Dosage and Administration (34068-7)
  • Clean the area.

  • Apply product to the operative site prior to surgery.
  • Apply with friction for 30 seconds.
  • Do not blot or wipe away.

Warnings and Precautions (34071-1)

For External Use Only

Section 42229-5 (42229-5)
  • Do not use in the eyes.
  • Discontinue use if irritation and redness develop.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Hold upright

Product # 119-XXU NDC: 68356-119-XX

Loris Povidone-Iodine [Solution]

[TEAR OPEN] [Tear here and pour]

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

[0.75 Fl. oz (22.5 mL)]

Antiseptic Solution

For hospital and professional use only

MANUFACTURED BY

LERNAPHARM (LORIS) INC.

2323 HALPERN, VILLE ST-LAURENT

QUEBEC, CANADA H4S 1S3

Section 53413-1 (53413-1)

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Povidone Iodine 10% w/v

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:28.460267 · Updated: 2026-03-06T01:18:05.484129