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

Active Ingredient

Povidone Iodine 10% w/v

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

Structured Label Content

Warnings and Precautions (34071-1)

For External Use Only

Active Ingredient (55106-9)

Povidone Iodine 10% w/v

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.

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

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