Prep Solution Topical Antiseptic Microbicide

Prep Solution Topical Antiseptic Microbicide
SPL v6
SPL
SPL Set ID dd34cc57-8a8c-4189-b517-61448f961c9e
Route
TOPICAL
Published
Effective Date 2022-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Anhydrous Glycerin Water Sodium Citrate Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01
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

Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings:

For external use only

Directions

For preparation of the skin prior to surgery:

Skin preparation for the skin: 1.Clean the area, 2. Apply product to the operative site prior to surgery.

For first aid antiseptic

1. Clean the affected area, 2. Apply a small amount of the product on the area 1-3 times daily, 3. May be covered with a sterile bandage, 4. If bandaged, let dry first. 

Drug Facts

Questions?

Call: 800-925-4733

Do Not Use:

In the eyes, on deep or puncture wounds, on individuals who are allergic or sensitive to iodine, as a first aid antiseptic longer than one week and in serious burns.

Active Ingredient

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

Other Information

Store at room temperature 20-25° C (68-77°F). Not made with natural rubber latex.

Package Labeling:

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Purified Water, Sodium Citrate, Tween 80.

Principal Display Panel

Stop Use and Ask A Doctor If

Irritation and redness develop and if conditions persist for more than 72 hours.

Keep Out of Reach of Children

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

Structured Label Content

Uses

Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Purpose

Antiseptic

Warnings:

For external use only

Directions

For preparation of the skin prior to surgery:

Skin preparation for the skin: 1.Clean the area, 2. Apply product to the operative site prior to surgery.

For first aid antiseptic

1. Clean the affected area, 2. Apply a small amount of the product on the area 1-3 times daily, 3. May be covered with a sterile bandage, 4. If bandaged, let dry first. 

Drug Facts

Questions?

Call: 800-925-4733

Do Not Use: (Do not use:)

In the eyes, on deep or puncture wounds, on individuals who are allergic or sensitive to iodine, as a first aid antiseptic longer than one week and in serious burns.

Active Ingredient

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

Other Information (Other information)

Store at room temperature 20-25° C (68-77°F). Not made with natural rubber latex.

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Citric Acid, Disodium Phosphate, Glycerin, Purified Water, Sodium Citrate, Tween 80.

Principal Display Panel

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

Irritation and redness develop and if conditions persist for more than 72 hours.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:16.525945 · Updated: 2026-03-14T23:01:41.296752