jek pvp-i swabstick (1's) and (3's)

jek pvp-i swabstick (1's) and (3's)
SPL v3
SPL
SPL Set ID 31d08e09-181b-3a7a-e063-6294a90aa757
Route
topical
Published
Effective Date 2025-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (10 mg)
Inactive Ingredients
water sodium hydroxide citric acid monohydrate nonoxynol-10 glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-15
Purpose

Antiseptic

Description

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Medication Information

Warnings

For external use only

If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.

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

Antiseptic

Directions

For preparation of the skin prior to surgery

  • clean the treatment area
  • remove applicator by end of swabstick
  • apply to the operative site prior to surgery
  • allow to dry

Other Information
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients

Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide

Description

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Section 51945-4

S41350 web NDC# 10819-3800-1

S41350 box NDC# 10819-3800-1

S41125 web NDC# 10819-3800-2

S41125 box NDC# 10819-3800-2

Do Not Use

Do not use

- in the eyes, nose or mouth

- on individuals who are allergic or sensitive to iodine

- over large areas of the body

Active Ingredient

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Keep Out of Reach of Children

Keep out of reach of children.

Structured Label Content

Warnings

For external use only

If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.

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

Antiseptic

Directions

For preparation of the skin prior to surgery

  • clean the treatment area
  • remove applicator by end of swabstick
  • apply to the operative site prior to surgery
  • allow to dry

Other Information (Other information)
  • Store at room temperature
  • Avoid excessive heat
Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide

Section 51945-4 (51945-4)

S41350 web NDC# 10819-3800-1

S41350 box NDC# 10819-3800-1

S41125 web NDC# 10819-3800-2

S41125 box NDC# 10819-3800-2

Do Not Use (Do not use)

Do not use

- in the eyes, nose or mouth

- on individuals who are allergic or sensitive to iodine

- over large areas of the body

Active Ingredient (Active ingredient)

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

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

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:07.562346 · Updated: 2026-03-14T23:13:46.303627