Active Ingredient
Chlorhexidine Gluconate 4%
Foster And Thrive Solution
FDA Label NDC 70677-1221
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Corporation for the product Foster And Thrive (NDC 70677-1221). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
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
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
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
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
Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
- 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
- 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
Healthcare personnel handwash:
Skin wound and general skin cleansing:
Other Information
- store at 20-25°C (68-77°F)
- avoid excessive heat about 40°C (104°F)
Inactive Ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Questions?
833-358-6431
Laundering/Cleaning Instructions
Chlorhexidine gluconate skin cleanser will cause stains if used with chlorine releasing products, such as chlorine bleach.
Distribution Statement
*This product is not manufactured or distributed by Molnlycke Healthcare, owner of Hibiclens®
REV. 10/23 4FT08BTLLBL
Prop 65 Statement
WARNING: Cancer - www.P65Warnings.co.giv
Distribution Block + Claim
©2023 McKesson Corporation
Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141
Money Back Guarantee www.fosterandthrive.com
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)
* Please review the disclaimer below.
