Medichoice Pvp Prep Solution

SPL v3

SPL

SPL Set ID 141c464f-a1ef-96d3-e063-6394a90a96a0

Route

TOPICAL

Published

Effective Date 2025-02-14

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, Dihydrate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-25

Description

Povidone-Iodine, USP 10% (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine, USP 10% (equivalent to 1% titratable 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

Clean the affected area
for preparation of the skin prior to surgery, apply product to the operative site
for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Do Not Use

in the eyes
on individuals who are allergic or sensitive to iodine
over large areas of the body
as first aid antiseptic longer than 1 week unless directed by doctor.

Drug Facts

Active Ingredient

Povidone-Iodine, USP 10% (equivalent to 1% titratable iodine)

Other Information

Store at room temperature 59º-86ºF (15º-30ºC)

Inactive Ingredients

citric acid monohydrate, sodium phosphate dibasic dihydrate, water

Keep Out of Reach of Children.

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

Package Labeling: 39892 0842 1

Package Labeling: 39892 0842 2

Stop Use and Consult A Doctor If

you have deep or puncture wounds
animal bites
serious burns
the condition persists or gets worse
irritation and redness develop

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

Clean the affected area
for preparation of the skin prior to surgery, apply product to the operative site
for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Do Not Use (Do not use)

in the eyes
on individuals who are allergic or sensitive to iodine
over large areas of the body
as first aid antiseptic longer than 1 week unless directed by doctor.

Drug Facts

Active Ingredient (Active ingredient)

Povidone-Iodine, USP 10% (equivalent to 1% titratable iodine)

Other Information (Other information)

Store at room temperature 59º-86ºF (15º-30ºC)

Inactive Ingredients (Inactive ingredients)

citric acid monohydrate, sodium phosphate dibasic dihydrate, 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.

Package Labeling: 39892 0842 1 (Package Labeling: 39892-0842-1)

Package Labeling: 39892 0842 2 (Package Labeling: 39892-0842-2)

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

you have deep or puncture wounds
animal bites
serious burns
the condition persists or gets worse
irritation and redness develop

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, DIHYDRATE", "unii": "94255I6E2T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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": "Clean the affected area for preparation of the skin prior to surgery, apply product to the operative site for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.", "Do not use": "in the eyes on individuals who are allergic or sensitive to iodine over large areas of the body as first aid antiseptic longer than 1 week unless directed by doctor.", "Active ingredient": "Povidone-Iodine, USP 10% (equivalent to 1% titratable iodine)", "Other information": "Store at room temperature 59º-86ºF (15º-30ºC)", "Inactive ingredients": "citric acid monohydrate, sodium phosphate dibasic dihydrate, water", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Stop use and consult a doctor if": "you have deep or puncture wounds animal bites serious burns the condition persists or gets worse irritation and redness develop"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:33.390792 · Updated: 2026-03-14T23:12:58.166895