Povidone Iodine Prep Pad

Povidone Iodine Prep Pad
SPL v3
SPL
SPL Set ID fcf27cbf-9535-1356-e053-6394a90a0362
Route
TOPICAL
Published
Effective Date 2023-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.1 g)
Inactive Ingredients
Polysorbate 80 Citric Acid Monohydrate Water Sodium Citrate Sodium Phosphate Dibasic Dihydrate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-30

Description

Povidone Iodine, 10% (equivalent 1% titratable Iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine, 10% (equivalent 1% titratable Iodine)

Uses:
  • First aid to help prevent infection in minor cuts, scrapes and burns
  • Patient preoperative skin preparation.Helps to reduce bacteria that potentially can cause skin infection.

Warnings:

For external use only.

Directions:
  • Tear at notch
  • Remove applicator
  • Discard applicator after single use.

As a first aid antispetic

  • Clean affected area
  • Apply 1 to 3 times daily.
  • May be covered with a sterile bandage
  • If bandaged, let dry first.

For preoperative patient skin preparation:

  • Clean area
  • Apply to operative site prior to surgery using applicator.

Do Not Use:
  • In the eyes
  • Longer than one week unless directed by a doctor
  • On individuals who are allergic or sensitive to iodine
  • Or apply over large areas of the body
Active Ingredient

Povidone Iodine, 10% (equivalent 1% titratable Iodine)

Other Information:
  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients:

Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, Water

Principal Display Panel

PROCURE

HEALTHCARE PRODUCTS

Single Pack

POVIDONE IODINE

SWABSTICKS

Antiseptic

50 Swabsticks Per Box

10 Boxes Per Case

500 Swabsticks Total

Stop Use and Ask A Doctor If:
  • Irritation and redness develops
  • If condition persists for more than 72 hours, consult a physician.
Keep Out of Reach of Children:

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

Ask A Doctor Before Use If You Have:
  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Structured Label Content

Uses:
  • First aid to help prevent infection in minor cuts, scrapes and burns
  • Patient preoperative skin preparation.Helps to reduce bacteria that potentially can cause skin infection.

Purpose

Antiseptic

Warnings:

For external use only.

Directions:
  • Tear at notch
  • Remove applicator
  • Discard applicator after single use.

As a first aid antispetic

  • Clean affected area
  • Apply 1 to 3 times daily.
  • May be covered with a sterile bandage
  • If bandaged, let dry first.

For preoperative patient skin preparation:

  • Clean area
  • Apply to operative site prior to surgery using applicator.

Do Not Use: (Do not use:)
  • In the eyes
  • Longer than one week unless directed by a doctor
  • On individuals who are allergic or sensitive to iodine
  • Or apply over large areas of the body
Active Ingredient

Povidone Iodine, 10% (equivalent 1% titratable Iodine)

Other Information:
  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients:

Citric Acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate UPS, Sodium Phosphate Dibasic, Water

Principal Display Panel

PROCURE

HEALTHCARE PRODUCTS

Single Pack

POVIDONE IODINE

SWABSTICKS

Antiseptic

50 Swabsticks Per Box

10 Boxes Per Case

500 Swabsticks Total

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Irritation and redness develops
  • If condition persists for more than 72 hours, consult a physician.
Keep Out of Reach of Children: (Keep out of reach of children:)

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

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Advanced Ingredient Data


Raw Label Data

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