2801aplicare Povidone Iodine Solution

2801aplicare Povidone Iodine Solution
SPL v8
SPL
SPL Set ID 1ad9237e-80ee-4769-ba53-9bc1bb667249
Route
TOPICAL
Published
Effective Date 2015-04-03
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 DRUG Active Since 1998-01-01
Description

Povidone-iodine 10% (equivalent to 1% available iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 10% (equivalent to 1% available iodine)

Use
  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation
Warnings
  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Directions
  • apply locally as needed
Do Not Use
  • • in the eyes
  • • on individuals allergic or sensitive to iodine
Package Label

Active Ingredient

Povidone-iodine 10%

(equivalent to 1% available iodine)

Other Information
  • • not made with natural rubber latex
  • • for hospital or professional use only
Inactive Ingredients

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

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Way, Meriden, CT 06450 USA

Made in USA

REF: APL82342K

RL17HND

Stop Use and Ask A Doctor If
  • • infection occurs
  • • redness, irritation, swelling or pain persists or increases
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If Injuries Are
  • • deep or puncture wounds
  • • serious burns

Structured Label Content

Use
  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation
Purpose

Antiseptic

Warnings
  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Directions
  • apply locally as needed
Do Not Use (Do not use)
  • • in the eyes
  • • on individuals allergic or sensitive to iodine
Package Label

Active Ingredient (Active ingredient)

Povidone-iodine 10%

(equivalent to 1% available iodine)

Other Information (Other information)
  • • 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

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Way, Meriden, CT 06450 USA

Made in USA

REF: APL82342K

RL17HND

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • • infection occurs
  • • redness, irritation, swelling or pain persists or increases
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)
  • • deep or puncture wounds
  • • serious burns

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:47.647827 · Updated: 2026-03-14T23:11:35.907821