Aplicare Povidone-iodine Paint

SPL v1

SPL

SPL Set ID 25319273-188a-4656-a867-c49e57919b27

Route

TOPICAL

Published

Effective Date 2017-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Sodium Phosphate, Dibasic Sodium Hydroxide Nonoxynol-9 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-05-31

Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

antiseptic skin preparation

Section 42229-5

Drug Facts

Section 44425-7

Avoid excessive heat. Store at room temperature.

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Section 53413-1

For questions, comments, or to report serious side effects:

800-760-3236

Monday-Friday 8:30 a.m.-5:00 p.m. EST

Directions

use sponge sticks to prep desired area

Do Not Use

if allergic to iodine
in the eyes

Active Ingredient

Povidone-iodine USP 10%

Other Information

1% titratable iodine
for single use only
not made with natural rubber latex
for hospital or professional use only

Inactive Ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Stop Use and Ask A Doctor If

redness, irritation, swelling or pain persists or increases
infection occurs

Ask A Doctor Before Use If Injuries Are

deep wounds
puncture wounds
serious burns

Principal Display Panel 2 Sponge Sticks Packet

NDC 52380-4011-2

A PLICARE

◀ Tear Here Hold Upright Tear Here ▶

TWO POVIDONE-IODINE PAINT

SPONGE STICKS

ANTISEPTIC

Non-Sterile Solution

Two 8-inch Sponge Sticks Saturated with

Povidone-Iodine USP, 1% Available Iodine

Reorder No. F-2011

Structured Label Content

Use

antiseptic skin preparation

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Avoid excessive heat. Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Section 53413-1 (53413-1)

For questions, comments, or to report serious side effects:

800-760-3236

Monday-Friday 8:30 a.m.-5:00 p.m. EST

Purpose

Antiseptic

Directions

use sponge sticks to prep desired area

Do Not Use (Do not use)

if allergic to iodine
in the eyes

Active Ingredient (Active ingredient)

Povidone-iodine USP 10%

Other Information (Other information)

1% titratable iodine
for single use only
not made with natural rubber latex
for hospital or professional use only

Inactive Ingredients (Inactive ingredients)

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

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

redness, irritation, swelling or pain persists or increases
infection occurs

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)

deep wounds
puncture wounds
serious burns

Principal Display Panel 2 Sponge Sticks Packet (PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet)

NDC 52380-4011-2

A PLICARE

◀ Tear Here Hold Upright Tear Here ▶

TWO POVIDONE-IODINE PAINT

SPONGE STICKS

ANTISEPTIC

Non-Sterile Solution

Two 8-inch Sponge Sticks Saturated with

Povidone-Iodine USP, 1% Available Iodine

Reorder No. F-2011

Advanced Ingredient Data

[{"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NONOXYNOL-9", "unii": "48Q180SH9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "antiseptic skin preparation", "42229-5": "Drug Facts", "44425-7": "Avoid excessive heat. Store at room temperature.", "50565-1": "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.", "53413-1": "For questions, comments, or to report serious side effects: 800-760-3236 Monday-Friday 8:30 a.m.-5:00 p.m. EST", "Purpose": "Antiseptic", "Directions": "use sponge sticks to prep desired area", "Do not use": "if allergic to iodine in the eyes", "Active ingredient": "Povidone-iodine USP 10%", "Other information": "1% titratable iodine for single use only not made with natural rubber latex for hospital or professional use only", "Inactive ingredients": "citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water", "Stop use and ask a doctor if": "redness, irritation, swelling or pain persists or increases infection occurs", "Ask a doctor before use if injuries are": "deep wounds puncture wounds serious burns", "PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet": "NDC 52380-4011-2 A PLICARE ◀ Tear Here Hold Upright Tear Here ▶ TWO POVIDONE-IODINE PAINT SPONGE STICKS ANTISEPTIC Non-Sterile Solution Two 8-inch Sponge Sticks Saturated with Povidone-Iodine USP, 1% Available Iodine Reorder No. F-2011"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.755373 · Updated: 2026-03-14T22:54:46.340416