Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 34769116-2520-f862-e063-6394a90a5949
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic Glycerin Water Sodium Citrate Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-06
Description

Povidone-Iodine 10% (equivalent to 1% titrable Iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine 10% (equivalent to 1% titrable Iodine)

Uses
  • First Aid for minor cuts, scrapes, and burns (helps prevent infection)
  • Preoperative skin prep (reduces bacteria)

Warning

For external use only.

Directions

As a first aid antiseptic:

  • Clean affected area
  • Apply a fingertip-sized amount 1-3 tmes daily
  • Cover with a sterile bandage if desired (allow to dry first)

For preoperative patient skin preparation:

  • Clean area
  • Apply before surgery
  • Let dry at least 2 minutes before draping
  • Remove soiled underdrapes
  • Avoid pooling
Do Not Use:
  • In eyes
  • More than week (unless advised by a doctor)
  • On those allergic/senstiive to iodine
  • Over large body areas
Active Ingredient

Povidone-Iodine 10% (equivalent to 1% titrable Iodine)

Other Information
  • Store at room temperature 20-25° C (68-77°F)
  • Avoid excessive heat
  • Not made with natural rubber latex
Inactive Ingredients

Citric acid, dibasic sodium phosphate, glycerin, polysorbate 80 (tween 80), sodium citrate, water.

Principal Display Panel

NDC 68786-010-89

SIONBIOTEXT

Prep Solution Topical Antiseptic Microbicide

10% POVIDONE IODINE

NET CONTENT

3 fl.oz. (89 ml)

NDC 68786-010-08

SIONBIOTEXT

Prep Solution Topical Antiseptic Microbicide

10% POVIDONE IODINE

NET CONTENT

8 Fl.oz. (236 ml)

Ask A Doctor Before Use If:
  • Deep or puncure wounds.
  • Animal Bites
  • Serious wounds
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately

Stop Use and Ask A Doctor If:
  • Irritation or redness appears
  • Condition lasts more than 72 hours

Structured Label Content

Uses
  • First Aid for minor cuts, scrapes, and burns (helps prevent infection)
  • Preoperative skin prep (reduces bacteria)

Purpose

Antiseptic

Warning

For external use only.

Directions

As a first aid antiseptic:

  • Clean affected area
  • Apply a fingertip-sized amount 1-3 tmes daily
  • Cover with a sterile bandage if desired (allow to dry first)

For preoperative patient skin preparation:

  • Clean area
  • Apply before surgery
  • Let dry at least 2 minutes before draping
  • Remove soiled underdrapes
  • Avoid pooling
Do Not Use:
  • In eyes
  • More than week (unless advised by a doctor)
  • On those allergic/senstiive to iodine
  • Over large body areas
Active Ingredient (Active ingredient)

Povidone-Iodine 10% (equivalent to 1% titrable Iodine)

Other Information
  • Store at room temperature 20-25° C (68-77°F)
  • Avoid excessive heat
  • Not made with natural rubber latex
Inactive Ingredients

Citric acid, dibasic sodium phosphate, glycerin, polysorbate 80 (tween 80), sodium citrate, water.

Principal Display Panel

NDC 68786-010-89

SIONBIOTEXT

Prep Solution Topical Antiseptic Microbicide

10% POVIDONE IODINE

NET CONTENT

3 fl.oz. (89 ml)

NDC 68786-010-08

SIONBIOTEXT

Prep Solution Topical Antiseptic Microbicide

10% POVIDONE IODINE

NET CONTENT

8 Fl.oz. (236 ml)

Ask A Doctor Before Use If: (Ask a doctor before use if:)
  • Deep or puncure wounds.
  • Animal Bites
  • Serious wounds
Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Irritation or redness appears
  • Condition lasts more than 72 hours

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.858236 · Updated: 2026-03-14T23:08:59.288880