939 Pvp Prep Solution

939 Pvp Prep Solution
SPL v20
SPL
SPL Set ID c9036a83-22f5-4a09-b01c-7093d4192c19
Route
TOPICAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Dihydrate Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01

Description

Povidone Iodine 10% (equivalent to 1% available iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine 10% (equivalent to 1% available iodine)

Uses
  • healthcare antiseptic for preparation of the skin prior to surgery
  • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Warnings

For external use only.

Directions

Clean the affected area.

  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • 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.
Do Not Use
  • in the eyes
  • longer than 1 week unless directed by a doctor
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body
Packaging Labels

Active Ingredient

Povidone Iodine 10%

(equivalent to 1% available iodine)

Other Information
  • protect from freezing, avoid excessive heat
Inactive Ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northifeld, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS093941

V1 RB22DYN

REF: 55114

V2 RB24HND

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

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


Structured Label Content

Uses
  • healthcare antiseptic for preparation of the skin prior to surgery
  • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Purpose

Antiseptic

Warnings

For external use only.

Directions

Clean the affected area.

  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • 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.
Do Not Use (Do not use)
  • in the eyes
  • longer than 1 week unless directed by a doctor
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body
Packaging Labels

Active Ingredient (Active ingredient)

Povidone Iodine 10%

(equivalent to 1% available iodine)

Other Information (Other information)
  • protect from freezing, avoid excessive heat
Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

Manufactured by:

Medline Industries, LP

Three Lakes Drive, Northifeld, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MDS093941

V1 RB22DYN

REF: 55114

V2 RB24HND

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
  • in case of deep or puncture wounds, animal bites or serious burns
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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