Op First Aid Series Povidone Iodine Prep Pad

Op First Aid Series Povidone Iodine Prep Pad
SPL v4
SPL
SPL Set ID b43ae55f-dc21-09b2-e053-2995a90adf4c
Route
TOPICAL
Published
Effective Date 2020-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Hydroxyethyl Cellulose, Unspecified Nonoxynol-10 Glycerin Sodium Hydroxide Potassium Iodide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-03

Description

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

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

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

Use
  • Antiseptic for preparation of the skin.
  • First aid antiseptic to help prevent skin infection.
Warnings

For external use only.

Directions

Clean intended area thoroughly with pad.discard after single use.

Stop Use 

In case of deep or puncture wounds or serious burns,and if pain,irritation, redness, swelling,or infection occurs,discontinue use and contact a physician.

Do Not Use 

Avoid contact with eyes.If happens,rinse thoroughly with water.

Other Information

Store at room temperature 15°C-30°C (59°F-86°F).

Package Labeling:

Active Ingredients

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

Inactive Ingredients

Citric Acid, Alkyl Glucoside,Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Use
  • Antiseptic for preparation of the skin.
  • First aid antiseptic to help prevent skin infection.
Purpose

Antiseptic

Warnings

For external use only.

Directions

Clean intended area thoroughly with pad.discard after single use.

Stop Use  (Stop use )

In case of deep or puncture wounds or serious burns,and if pain,irritation, redness, swelling,or infection occurs,discontinue use and contact a physician.

Do Not Use  (Do not use )

Avoid contact with eyes.If happens,rinse thoroughly with water.

Other Information (Other information)

Store at room temperature 15°C-30°C (59°F-86°F).

Package Labeling:

Active Ingredients

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

Inactive Ingredients (Inactive ingredients)

Citric Acid, Alkyl Glucoside,Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water.

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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