First Aid Only Povidone-iodine Antiseptic Pad

First Aid Only Povidone-iodine Antiseptic Pad
SPL v2
SPL
SPL Set ID e0052ac2-4f74-32a4-e053-2995a90a94c6
Route
TOPICAL
Published
Effective Date 2022-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 g)
Inactive Ingredients
Nonoxynol-10 Hydroxyethyl Cellulose, Unspecified Potassium Iodide Sodium Hydroxide Glycerin Citric Acid Monohydrate Water C12-20 Alkyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-03

Description

Povidone-lodine 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-lodine 10%

Use

First aid antiseptic to help prevent skin infection

Section 51945-4

Pouch label

Warnings

For external use only

Do Not Use

▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients

▪ longer than 1 week unless directed by a doctor

.

Driections

Open packet and wipe affected area. Apply 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Drug Facts

Active Ingredient

Povidone-lodine 10%

Other Information

Store at room temperature.

Inactive Ingredients:

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,

purified water, sodium hydroxide

Stop Use and Ask A Doctor If

▪ conditions worsen or clear up and then recur

▪ the condition persists for more than 7 days

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

▪ deep or puncture wounds ▪ animal bites ▪ serious burns


Structured Label Content

Use

First aid antiseptic to help prevent skin infection

Section 51945-4 (51945-4)

Pouch label

Purpose

Antiseptic

Warnings

For external use only

Do Not Use (Do not use)

▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients

▪ longer than 1 week unless directed by a doctor

.

Driections

Open packet and wipe affected area. Apply 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Drug Facts

Active Ingredient (Active ingredient)

Povidone-lodine 10%

Other Information (Other information)

Store at room temperature.

Inactive Ingredients: (Inactive ingredients:)

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,

purified water, sodium hydroxide

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

▪ conditions worsen or clear up and then recur

▪ the condition persists for more than 7 days

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.

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

All Sections (JSON)