FOSTER AND THRIVE- chlorhexidine gluconate 4% solution

Foster and Thrive by

Drug Labeling and Warnings

Foster and Thrive by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chlorhexidine Gluconate 4%

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.

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

Other information

• store at 20-25ºC (68-77ºF)
• avoid excessive heat about 40ºC (104ºF)

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)

INGREDIENTS AND APPEARANCE

FOSTER AND THRIVE 
chlorhexidine gluconate 4% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-1221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
TRIDECYL ALCOHOL (UNII: 8I9428H868)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-1221-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	10/27/2023

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-1221)