1425, 1426

1425, 1426
SPL v4
SPL
SPL Set ID 6f053e55-cbf6-9072-e053-2991aa0a2edd
Route
TOPICAL
Published
Effective Date 2018-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Water Sodium Phosphate, Dibasic, Anhydrous Hydroxyethyl Cellulose (100 Mpa.s At 2%) Monoethanolamine Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-08
Description

Povidone-iodine 7.5%

Purpose

Healthcare Antiseptic

Medication Information

Purpose

Healthcare Antiseptic

Description

Povidone-iodine 7.5%

Uses
  • Surgical hand scrub which significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
  • Preoperative skin preparation for the preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection
Other

Store at controlled room temperature.

Section 50565-1

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

Labeling

Warnings

For external use only

Directions
  • Surgical hand scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for five minutes paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub.
  • Preoperative skin preparation: Clean the area. Apply product to the operative site prior to surgery.
Do Not Use
  • if allergic to iodine
  • in the eyes
Questions?

1-888-DYNAREX

Active Ingredient

Povidone-iodine 7.5%

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours

Structured Label Content

Uses
  • Surgical hand scrub which significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
  • Preoperative skin preparation for the preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection
Other

Store at controlled room temperature.

Section 50565-1 (50565-1)

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

Purpose

Healthcare Antiseptic

Labeling

Warnings

For external use only

Directions
  • Surgical hand scrub: Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for five minutes paying particular attention to the nails, cuticles, and interdigital spaces. Rinse and repeat scrub.
  • Preoperative skin preparation: Clean the area. Apply product to the operative site prior to surgery.
Do Not Use
  • if allergic to iodine
  • in the eyes
Questions?

1-888-DYNAREX

Active Ingredient

Povidone-iodine 7.5%

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • condition persists for more than 72 hours

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:29.260503 · Updated: 2026-03-14T23:05:15.511736