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| Product NDC Code | 0116-1221 | ||||
|---|---|---|---|---|---|
| Drug Name | Foster and thrive |
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| Type | Brand | ||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 211365 | ||||
| Application Number | NDA019125 | ||||
| Labeler Name | Xttrium Laboratories, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Chlorhexidine Gluconate 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses healthcare personnel handwash : helps reduce bacteria that potentially can cause disease skin wound and general skin cleansing
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Foster and Thrive Chlorhexidine Gluconate 4% WATER CHLORHEXIDINE GLUCONATE CHLORHEXIDINE ISOPROPYL ALCOHOL LAURAMINE OXIDE GLUCONOLACTONE PEG-75 LANOLIN COCO DIETHANOLAMIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) TRIDECYL ALCOHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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) Foster & Thrive 8oz Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 833-358-6431
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Distribution Statement *This product is not manufactured or distributed by Molnlycke Healthcare, owner of Hibiclens® REV. 10/23 4FT08BTLLBL
Distribution Block + Claim ©2023 McKesson Corporation Distributed by : McKesson Corp., via SSSL, Memphis, TN 38141 Money Back Guarantee www.fosterandthrive.com
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25ºC (68-77ºF) avoid excessive heat about 40ºC (104ºF)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API