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| Product NDC Code | 0116-1061 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Antiseptic skin cleanser |
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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
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.Direction use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces a separate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 ml of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Skin wound and general skin cleaning: thoroughly 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 thoroughly
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 surgical hand scrub : significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care 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.ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) ISOPROPYL ALCOHOL LAURAMINE OXIDE WATER TRIDECYL ALCOHOL GLUCONOLACTONE PEG-75 LANOLIN CHLORHEXIDINE GLUCONATE CHLORHEXIDINE COCO DIETHANOLAMIDE
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.Package label and principal display panel NDC 0116-1061-08 DYNA-HEX 4 ® (Chlorhexidine Gluconate 4% Solution) Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 8 fl oz (237 mL) 4DY08BTLLBLF NDC 0116-1061-16 DYNA-HEX 4 ® (Chlorhexidine Gluconate 4% Solution) Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 16 fl oz (473 mL) 4DY16BTLLBLF NDC 0116-1061-32 DYNA-HEX 4 ® (Chlorhexidine Gluconate 4% Solution) Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 32 fl oz (946 mL) 4DY32BTLLBLB NDC 0116-1061-01 DYNA-HEX 4 ® (Chlorhexidine Gluconate 4% Solution) Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 128 fl oz (1 gal) 4DYN1GBTLLBLC NDC 0116-1061-40 DYNA-HEX 4® Chlorhexidine Gluconate 4% Solution Antiseptic Contains: 4% Chlorhexidine Gluconate With foam pump Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 4 fl oz (118mL) 4DY04FM1061LBLB NDC 0116-1061-18 DYNA-HEX 4® Chlorhexidine Gluconate 4% Solution Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 FOR EXTERNAL USE ONLY Net Contents: 18 fl oz (532mL) 4DY18FM1061LBLB 4 Dyna-Hex 8oz Single Panel 16oz Dyna-Hex 4 single panel Dyna-Hex 4 32oz 1 Gallon Dyna-Hex 4 4oz FM Dyna-Hex 4 18oz Dyna-Hex 4 single panel
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 irritation, sensitization, or allergic reaction occurs. These 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 genital area as a preoperative skin preparation of the head or face (only in 4-oz)
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 genital 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. If swallowed, get medical help or contact a Poison Control Center right away.
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 or comments? call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition
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. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when advised by a health care provider
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. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas shold not be done except when advised by a health care provider
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20-25ºC (68-77ºF) avoid excessive heat above 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 cause 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 genital area as a preoperative skin preparation of the head or face (only in 4-oz) 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. if solution should contact these areas, rinse out promptly and thoroughly with water wounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when advised by a health care provider Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. 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