0946 Aplicare 10% Povidone-iodine Swabsticks

0946 Aplicare 10% Povidone-iodine Swabsticks
SPL v3
SPL
SPL Set ID 0b3e4f14-e9e6-2f2e-e063-6394a90ab2e1
Route
TOPICAL
Published
Effective Date 2024-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-27

Description

Povidone-iodine USP 10% w/w

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10% w/w

Uses
  • antiseptic skin preparation
  • first aid to help prevent infection in minor cuts, scrapes, and burns
Warnings

Do not use

  • if allergic to iodine
  • in the eyes
  • or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

For external use only

Directions
  • clean the affected area
  • for first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Package Label

Active Ingredient

Povidone-iodine USP 10% w/w

Other Information
  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • for single use only
  • protect from freezing, avoid excessive heat
Inactive Ingredients

citric acid, disodium phosphate, purified water

Manufacturer Information

www.medline.com ©2024 Medline Industries, LP

Aplicare is a registered trademark of Medline Industries, LP.

Manufactured for Medline Industries, LP, Three Lakes Drive,

Northfield, IL 60093 USA. Made in China. 1-800-MEDLINE.

V1 RI24LPD

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours or gets worse
  • in case of deep or puncture wounds, animal bites, or serious burns

Avoid pooling beneath patient

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
  • antiseptic skin preparation
  • first aid to help prevent infection in minor cuts, scrapes, and burns
Purpose

Antiseptic

Warnings

Do not use

  • if allergic to iodine
  • in the eyes
  • or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

For external use only

Directions
  • clean the affected area
  • for first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
Package Label (Package label)

Active Ingredient (Active ingredient)

Povidone-iodine USP 10% w/w

Other Information (Other information)
  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • for single use only
  • protect from freezing, avoid excessive heat
Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, purified water

Manufacturer Information (Manufacturer information)

www.medline.com ©2024 Medline Industries, LP

Aplicare is a registered trademark of Medline Industries, LP.

Manufactured for Medline Industries, LP, Three Lakes Drive,

Northfield, IL 60093 USA. Made in China. 1-800-MEDLINE.

V1 RI24LPD

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 or gets worse
  • in case of deep or puncture wounds, animal bites, or serious burns

Avoid pooling beneath patient

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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