Xtt Comp Foster & Thrive 4% Chg Antiseptic Skin Cleanser 8oz

Xtt Comp Foster & Thrive 4% Chg Antiseptic Skin Cleanser 8oz
SPL v3
SPL
SPL Set ID 0ce1b132-1f2d-d344-e063-6394a90a57d7
Route
TOPICAL
Published
Effective Date 2023-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Water Isopropyl Alcohol Lauramine Oxide Gluconolactone Peg-75 Lanolin Coco Diethanolamide Hydroxyethyl Cellulose (2000 Cps At 1%) Tridecyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Completed Since 2023-10-27 Until 2027-01-31

Description

Chlorhexidine Gluconate 4%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine Gluconate 4%

Uses
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing
Warnings

For external use only

Allergy alert:

This product may casue 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

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in vigorous manner for about 15 seconds
  • rinse and dry throughly

Skin wound and general skin cleansing:

  • throughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again throughly

Do Not Use
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the gential area
Questions?

833-358-6431

Active Ingredient

Chlorhexidine Gluconate 4%

Other Information
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat about 40ºC (104ºF)
Prop 65 Statement

WARNING: Cancer - www.P65Warnings.co.giv

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Distribution Statement

*This product is not manufactured or distributed by Molnlycke Healthcare, owner of Hibiclens®

REV. 10/23 4FT08BTLLBL

Principle Display Panel

NDC 70677-1221-1

Compared to the Active Ingredient in Hibiclens®

Foster & Thrive™

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Dye Free

For External Use Only

8 FL OZ (237 mL)

When Using This Product
  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
  • is solution should contact these areas, rinse out promptly and throughly with water
  • wounds which involve more than the superfical layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done expect when advised by health care provider
Distribution Block + Claim

©2023 McKesson Corporation

Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141

Money Back Guarantee www.fosterandthrive.com

Stop Use and Ask A Doctor If

Stop use and ask a doctor if irritation , sensitization, or allergic reaction occurs. There 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 Poison Control Center right away

Laundering/cleaning Instructions

Chlorhexidine gluconate skin cleanser will cause stains if used with chlorine releasing products, such as chlorine bleach.


Structured Label Content

Uses
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing
Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

This product may casue 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

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in vigorous manner for about 15 seconds
  • rinse and dry throughly

Skin wound and general skin cleansing:

  • throughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again throughly

Do Not Use (Do not use)
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the gential area
Questions?

833-358-6431

Active Ingredient

Chlorhexidine Gluconate 4%

Other Information (Other information)
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat about 40ºC (104ºF)
Prop 65 Statement (Prop 65 statement)

WARNING: Cancer - www.P65Warnings.co.giv

Inactive Ingredients (Inactive ingredients)

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Distribution Statement

*This product is not manufactured or distributed by Molnlycke Healthcare, owner of Hibiclens®

REV. 10/23 4FT08BTLLBL

Principle Display Panel

NDC 70677-1221-1

Compared to the Active Ingredient in Hibiclens®

Foster & Thrive™

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Dye Free

For External Use Only

8 FL OZ (237 mL)

When Using This Product (When using this product)
  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
  • is solution should contact these areas, rinse out promptly and throughly with water
  • wounds which involve more than the superfical layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done expect when advised by health care provider
Distribution Block + Claim

©2023 McKesson Corporation

Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141

Money Back Guarantee www.fosterandthrive.com

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

Stop use and ask a doctor if irritation , sensitization, or allergic reaction occurs. There may be signs of a serious condition

Keep Out of Reach of Children. (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

Laundering/cleaning Instructions (Laundering/Cleaning Instructions)

Chlorhexidine gluconate skin cleanser will cause stains if used with chlorine releasing products, such as chlorine bleach.


Advanced Ingredient Data


Raw Label Data

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