Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 05a532c0-713f-4acf-bdf3-8cda55cfe132
Route
TOPICAL
Published
Effective Date 2012-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Dihydrate Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-06-13

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

First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Directions
  • Clean the affected area.
  • 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 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 to 1% available iodine)

Other Information

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Stop Use and Ask A Doctor
  • if irritation and redness develop
  • if 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.

Package/label Principal Display Panel

Walgreens

Apothecary

Povidone Iodine

10% Topical Solution

Topical antiseptic germicide

Helps prevent infection

  • burns
  • cuts
  • minor skin wounds
  • scrapes

FOR EXTERNAL USE ONLY

8 FL OZ (236 mL)


Structured Label Content

Uses

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.
  • 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 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 (Active ingredient)

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

Other Information

Protect from freezing. Avoid excessive heat.

Inactive Ingredients (Inactive ingredients)

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if irritation and redness develop
  • if 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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Walgreens

Apothecary

Povidone Iodine

10% Topical Solution

Topical antiseptic germicide

Helps prevent infection

  • burns
  • cuts
  • minor skin wounds
  • scrapes

FOR EXTERNAL USE ONLY

8 FL OZ (236 mL)


Advanced Ingredient Data


Raw Label Data

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