125 Medline Pvp-i Gel Swabstick

125 Medline Pvp-i Gel Swabstick
SPL v4
SPL
SPL Set ID 1d731a44-f16e-c249-e063-6294a90a39b8
Route
TOPICAL
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Glycerin Nonoxynol-2 Hydroxyethyl Cellulose, Unspecified Water Sodium Phosphate, Dibasic, Anhydrous Dodecamethylpentasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

Povidone-iodine USP 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Uses
  • for preparation of the skin prior to surgery
  • helps reduce bacteria that potentially can cause skin infection
Warnings

For external use only

Directions

swab locally as needed

Do Not Use
  • if allergic to iodine
  • in the eyes
  • on children less than 3 years old
Package Label

Active Ingredient

Povidone-iodine USP 10%

Other Information
  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • store product upright
  • protect from freezing, avoid excessive heat
Discontinue Use If
  • irritation and redness develop. If condition persists for more than 72 hours consult a doctor
Inactive Ingredients

disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water

Major Change Section

Update made to Uses and Directions

Manufacturing Information

www.medline.com

©2024 Medline Industries, LP

Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

Made in China.

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


Structured Label Content

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

Antiseptic

Warnings

For external use only

Directions

swab locally as needed

Do Not Use (Do not use)
  • if allergic to iodine
  • in the eyes
  • on children less than 3 years old
Package Label (Package label)

Active Ingredient

Povidone-iodine USP 10%

Other Information
  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • store product upright
  • protect from freezing, avoid excessive heat
Discontinue Use If (Discontinue use if)
  • irritation and redness develop. If condition persists for more than 72 hours consult a doctor
Inactive Ingredients (Inactive ingredients)

disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water

Major Change Section (major change section)

Update made to Uses and Directions

Manufacturing Information (Manufacturing information)

www.medline.com

©2024 Medline Industries, LP

Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

Made in China.

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

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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