1905 10% Pvp-i Scrub, Non-sterile

1905 10% Pvp-i Scrub, Non-sterile
SPL v18
SPL
SPL Set ID 7302a2f8-a600-4200-bc4e-309e4c190fe5
Route
TOPICAL
Published
Effective Date 2017-01-01
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 DRUG Completed Since 1998-09-01 Until 2022-06-01

Description

Povidone-iodine USP 10%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-iodine USP 10%

Uses
  • antiseptic skin preparation
  • single use when used for patient preoperative skin preparation and/or preinjection indications.
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 USP 10%

Other Information
  • 1% titratable iodine
  • not made with Natural Rubber Latex
  • for hospital or professional use only
Inactive Ingredients

• citric acid

• disodium phosphate

• nonoxynol-9

• sodium hydroxide

• water

Questions Or Comments?

1 800-633-5463

Monday - Friday

8:30 AM -5:00 PM EST

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APL82332

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

Uses
  • antiseptic skin preparation
  • single use when used for patient preoperative skin preparation and/or preinjection indications.
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 USP 10%

Other Information (Other information)
  • 1% titratable iodine
  • 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

Questions Or Comments? (Questions or comments?)

1 800-633-5463

Monday - Friday

8:30 AM -5:00 PM EST

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA with domestic and foreign materials

1-800-633-5463

REF: APL82332

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)