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| Product NDC Code | 0116-1060 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Dyna-hex 4 |
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| Type | Brand | ||||||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LIQUID | ||||||||
| RxCUI drug identifier | 211365, 834162 |
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| Application Number | NDA019127 | ||||||||
| 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% solution
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. Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with about 2.0 cubic inches 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 scrub for an additional 3 minutes with 2.0 cubic inches of product and rinse under running water dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 1.5 cubic inches of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.cocamide DEA, fragrance, glucono-delta-lactone, 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
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.Dyna-Hex 4 Chlorhexidine Gluconate PEG-75 LANOLIN ISOPROPYL ALCOHOL GLUCONOLACTONE WATER CHLORHEXIDINE GLUCONATE CHLORHEXIDINE LAURAMINE OXIDE TRIDECYL ALCOHOL 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.Principle Display Panel NDC 0116-1060-32 DYNA-HEX 4® Chlorhexidine Gluconate 4% Solution Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 CHLORHEXIDINE GLUCONATE Net Contents: 32 fl oz (1 qt) (946 mL) 4DYN32RNDLBL NDC 0116-1060-33 DYNA-HEX 4® Chlorhexidine Gluconate 4% Solution Antiseptic Contains: 4% Chlorhexidine Gluconate Distributed By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 CHLORHEXIDINE GLUCONATE Net Contents: 32 fl oz (1 qt) (946 mL) 4DYN32SQLBL Dyna-Hex 32oz RND 32oz Dyna-Hex 4 SQ
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 are allergic to chlorhexidine gluconate or any other ingredient in this product
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.To Install: Remove bottle cap and apply dispensing cap. Slide dispenser into bracket, inserting the open air inlet onto proper receptacle Container is single use only. Discard when empty.
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
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
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
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 are allergic to chlorhexidine gluconate or any other ingredient in this 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 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