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

Purpose

Antiseptic

Description

Drug Facts


Medication Information

Warnings

For External Use Only

Purpose

Antiseptic

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.

Inactive Ingredients

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

Description

Drug Facts

Principal Display Panel

Use

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

Section 42229-5

Drug Facts

Active Ingredient

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

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

Warnings

For External Use Only

Purpose

Antiseptic

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.

Inactive Ingredients

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

Principal Display Panel

Use

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

Section 42229-5 (42229-5)

Drug Facts

Active Ingredient

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

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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