Label: FOSTER AND THRIVE- chlorhexidine gluconate 4% solution
- NDC Code(s): 0116-1221-01
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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
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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
- Inactive ingredients
- Questions?
- Laundering/Cleaning Instructions
- Distribution Statement
- Prop 65 statement
- Distribution Block + Claim
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
FOSTER AND THRIVE
chlorhexidine gluconate 4% solutionProduct 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)
