Quality Choice Povidone Iodine

Quality Choice Povidone Iodine
SPL v6
SPL
SPL Set ID 9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d
Route
TOPICAL
Published
Effective Date 2014-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-01-01

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

First aid antiseptic to prevent infection in minor cuts and burns.

Section 42229-5

Drug Facts

Warnings

For External Use Only

Directions

For preparation of the skin prior to surgery. Apply to the operative site prior to surgery.

As a first aid antiseptic. Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

Active Ingredient

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

Principal Display Panel

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

When Using This Product Do Not
  • use in eyes
  • use on individuals who are allergic or sensitive to iodine or use for longer thn 1 week unless directed by a doctor
  • apply over large areas of the body
Stop Use and Consult A Doctor If
  • the condition persists or gets worse
  • irritation and redness develop and persits for more than 72 hours
Ask A Doctor Before Use If You Have
  • deep punture wounds
  • animal bites
  • serious burns

Structured Label Content

Use

First aid antiseptic to prevent infection in minor cuts and burns.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antiseptic

Warnings

For External Use Only

Directions

For preparation of the skin prior to surgery. Apply to the operative site prior to surgery.

As a first aid antiseptic. Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If badaged, let it dry first.

Active Ingredient

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

Principal Display Panel

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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

When Using This Product Do Not (When using this product do not)
  • use in eyes
  • use on individuals who are allergic or sensitive to iodine or use for longer thn 1 week unless directed by a doctor
  • apply over large areas of the body
Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • the condition persists or gets worse
  • irritation and redness develop and persits for more than 72 hours
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep punture wounds
  • animal bites
  • serious burns

Advanced Ingredient Data


Raw Label Data

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