244 readyprep chg

244 readyprep chg
SPL v11
SPL
SPL Set ID 458cf999-5e3d-4d4d-82d5-02118c331893
Route
topical
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlorhexidine (500 mg)
Inactive Ingredients
glycerin water dimethicone 350 propylene glycol benzalkonium chloride isopropyl alcohol

Identifiers & Packaging

Marketing Status
nda active Since 2019-01-14

Purpose

Antiseptic

Description

Chlorhexidine gluconate 2% solution


Medication Information

Recent Major Changes

December 2022: Additional verbiage added to " Directions " section due to the 6 count product (NDC: 53329-244-03) being added to the SPL per S-003 (supplement 3).

Warnings

For external use only

Uses
  • helps reduce bacteria that can potentially cause skin infection
  • for preparation of skin prior to surgery
Purpose

Antiseptic

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • do not microwave
  • product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.
  • to open package: identify the tear notch labeled on the front of the package. Grasp with both hands on both sides of the tear notch and tear to expose cloth.
  • transfer contents onto prep table, avoiding contact between cloth and outside of package to reduce risk of cloth contamination
  • use [first/a] cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the [second/remaining] cloth[s] where it will not be contaminated. Use [second/additional] cloth to prepare larger areas.
  • dry surgical sites: (such as abdomen or arm): use one cloth to cleanse each 161 cm 2 area (approximately) 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to dry for one (1) minute. Do not rinse.
  • moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm 2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, competely wetting treatment area, then discard. Allow area to dry for one (1) minute. Do not rinse.
  • discard each cloth after a single use
  • after package has been opened, discard any unused cloths
Other Information
  • store product flat
  • store between 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients
  • benzalkonium chloride
  • dimethicone emulsion
  • glycerin
  • isopropyl alcohol
  • propylene glycol
  • purified water USP
Description

Chlorhexidine gluconate 2% solution

Do Not Use
  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar punctures or in contact with the meninges
  • on open skin wounds
  • as a general skin cleanser
Allergy Alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient

Chlorhexidine gluconate 2% solution

When Using This Product
  • keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Package Label 2 Cloths

Package Label 6 Cloths

Manufacturing Information

DO NOT FLUSH

Non-Sterile.

Product is not made with Natural Rubber Latex.

Cloth: 100% Polyester

REF MSC098CHG, MSC099CHG

www.medline.com

©2021 Medline Industries, LP

Medline is a registered trademark of Medline Industries, LP

Manufactured by

Medline Industries, LP

Northfield, IL 60093 USA.

Made in USA with domestic and foreign materials.

Patent Pending

Questions, comments, or ordering call: 1-800-MEDLINE (633-5463)

Customer Service Hours:

(Monday to Friday, 7 AM to 7 PM CST)

V1 RK21MSC, V1 RJ22MSC

Stop Use and Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Posion Control Center right away.


Structured Label Content

Recent Major Changes

December 2022: Additional verbiage added to " Directions " section due to the 6 count product (NDC: 53329-244-03) being added to the SPL per S-003 (supplement 3).

Warnings

For external use only

Uses
  • helps reduce bacteria that can potentially cause skin infection
  • for preparation of skin prior to surgery
Purpose

Antiseptic

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • do not microwave
  • product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.
  • to open package: identify the tear notch labeled on the front of the package. Grasp with both hands on both sides of the tear notch and tear to expose cloth.
  • transfer contents onto prep table, avoiding contact between cloth and outside of package to reduce risk of cloth contamination
  • use [first/a] cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the [second/remaining] cloth[s] where it will not be contaminated. Use [second/additional] cloth to prepare larger areas.
  • dry surgical sites: (such as abdomen or arm): use one cloth to cleanse each 161 cm 2 area (approximately) 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to dry for one (1) minute. Do not rinse.
  • moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm 2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, competely wetting treatment area, then discard. Allow area to dry for one (1) minute. Do not rinse.
  • discard each cloth after a single use
  • after package has been opened, discard any unused cloths
Other Information (Other information)
  • store product flat
  • store between 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)
  • benzalkonium chloride
  • dimethicone emulsion
  • glycerin
  • isopropyl alcohol
  • propylene glycol
  • purified water USP
Do Not Use (Do not use)
  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar punctures or in contact with the meninges
  • on open skin wounds
  • as a general skin cleanser
Allergy Alert: (Allergy alert:)

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient (Active ingredient)

Chlorhexidine gluconate 2% solution

When Using This Product (When using this product)
  • keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
Package Label 2 Cloths (Package Label - 2 Cloths)

Package Label 6 Cloths (Package Label - 6 Cloths)

Manufacturing Information

DO NOT FLUSH

Non-Sterile.

Product is not made with Natural Rubber Latex.

Cloth: 100% Polyester

REF MSC098CHG, MSC099CHG

www.medline.com

©2021 Medline Industries, LP

Medline is a registered trademark of Medline Industries, LP

Manufactured by

Medline Industries, LP

Northfield, IL 60093 USA.

Made in USA with domestic and foreign materials.

Patent Pending

Questions, comments, or ordering call: 1-800-MEDLINE (633-5463)

Customer Service Hours:

(Monday to Friday, 7 AM to 7 PM CST)

V1 RK21MSC, V1 RJ22MSC

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

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Posion Control Center right away.


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Raw Label Data

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