938 Readyscrub Pvp

938 Readyscrub Pvp
SPL v8
SPL
SPL Set ID 2b95078e-2caf-7005-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2019-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (0.75 g)
Inactive Ingredients
Ammonium Nonoxynol-4 Sulfate Nonoxynol-5 Citric Acid Monohydrate Sodium Phosphate, Dibasic, Dihydrate Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01

Description

Povidone-Iodine 7.5% w/v (equivalent to 0.75% available iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-Iodine 7.5% w/v (equivalent to 0.75% available iodine)

Uses
  • for preparation of the skin prior to surgery
  • helps to reduce bacteria that potentially can cause skin infection
  • significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • single use when used for patient preoperative skin preparation
Warnings

For external use only

Directions
  • apply topically as needed
Do Not Use
  • in the eyes
  • if you are allergic to iodine or any of the other ingredients in the product
Major Change

Update to Directions to remove "follow with application of Medline Prep Solution and allow to dry".

Package Label

Active Ingredient

Povidone-Iodine 7.5% w/v



(equivalent to 0.75% available iodine)

Other Information
  • protect from freezing, avoid excessive heat
Inactive Ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

When Using This Product
  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient
Manufactuing Information

www.medline.com

Manufactured in USA by Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

REF: MDS093947

Stop Use and Ask A Doctor
  • if irritation and redness develop
  • if condition persists for more than 72 hours
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison control center right away.


Structured Label Content

Uses
  • for preparation of the skin prior to surgery
  • helps to reduce bacteria that potentially can cause skin infection
  • significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • single use when used for patient preoperative skin preparation
Purpose

Antiseptic

Warnings

For external use only

Directions
  • apply topically as needed
Do Not Use (Do not use)
  • in the eyes
  • if you are allergic to iodine or any of the other ingredients in the product
Major Change

Update to Directions to remove "follow with application of Medline Prep Solution and allow to dry".

Package Label

Active Ingredient (Active ingredient)

Povidone-Iodine 7.5% w/v



(equivalent to 0.75% available iodine)

Other Information (Other information)
  • protect from freezing, avoid excessive heat
Inactive Ingredients (Inactive ingredients)

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

When Using This Product (When using this product)
  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient
Manufactuing Information

www.medline.com

Manufactured in USA by Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

REF: MDS093947

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if irritation and redness develop
  • if condition persists for more than 72 hours
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.


Advanced Ingredient Data


Raw Label Data

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