Aplicare Povidone-iodine Scrub Small Wing Sponge

Aplicare Povidone-iodine Scrub Small Wing Sponge
SPL v1
SPL
SPL Set ID 4f8a29aa-8f0f-4c62-8552-54b8bba9a613
Route
TOPICAL
Published
Effective Date 2017-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Sodium Phosphate, Dibasic, Unspecified Form Anhydrous Citric Acid Sodium Hydroxide Nonoxynol-9 Ammonium Nonoxynol-4 Sulfate 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 sponges 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

ammonium nonoxynol-4 sulfate, 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

For external use only

Ask A Doctor Before Use If Injuries Are
  • deep wounds
  • puncture wounds
  • serious burns
Principal Display Panel 4 Sponge Packet

NDC 52380-5124-4

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

FOUR POVIDONE-IODINE SCRUB

SMALL WINGED SPONGES

ANTISEPTIC

Non-Sterile Solution

Four Small Winged Sponges Saturated with

Povidone-Iodine Scrub USP

Reorder No. F-4012


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 sponges 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)

ammonium nonoxynol-4 sulfate, 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

For external use only

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 4 Sponge Packet (PRINCIPAL DISPLAY PANEL - 4 Sponge Packet)

NDC 52380-5124-4

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

FOUR POVIDONE-IODINE SCRUB

SMALL WINGED SPONGES

ANTISEPTIC

Non-Sterile Solution

Four Small Winged Sponges Saturated with

Povidone-Iodine Scrub USP

Reorder No. F-4012


Advanced Ingredient Data


Raw Label Data

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