Antiseptic Skin Cleanser
Chlorhexidine Gluconate
Xttrium Laboratories, Inc.
Human Otc Drug
NDC 0116-1061Antiseptic Skin Cleanser also known as Chlorhexidine Gluconate is a human otc drug labeled by 'Xttrium Laboratories, Inc.'. National Drug Code (NDC) number for Antiseptic Skin Cleanser is 0116-1061. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Antiseptic Skin Cleanser drug includes Chlorhexidine Gluconate - 4 g/100mL . The currest status of Antiseptic Skin Cleanser drug is Active.
Drug Information:
| Drug NDC: | 0116-1061 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Antiseptic Skin Cleanser |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Chlorhexidine Gluconate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Xttrium Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHLORHEXIDINE GLUCONATE - 4 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 31 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA019125 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Xttrium Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 211365
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0011610611609
0011610613207
0011610610107
0301161061085
|
| UPC stands for Universal Product Code. |
| UNII: | MOR84MUD8E
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Cell Wall Integrity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0116-1061-01 | 15142 mL in 1 JUG (0116-1061-01) | 31 Aug, 2011 | N/A | No |
| 0116-1061-08 | 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) | 31 Aug, 2011 | N/A | No |
| 0116-1061-16 | 437 mL in 1 BOTTLE, PLASTIC (0116-1061-16) | 31 Aug, 2011 | N/A | No |
| 0116-1061-18 | 532 mL in 1 BOTTLE (0116-1061-18) | 31 Aug, 2011 | N/A | No |
| 0116-1061-32 | 946 mL in 1 BOTTLE, PLASTIC (0116-1061-32) | 31 Aug, 2011 | N/A | No |
| 0116-1061-40 | 118 mL in 1 BOTTLE (0116-1061-40) | 01 Jan, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic
Product Elements:
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
Indications and Usage:
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
Warnings:
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 c
Read more...are 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.
Do Not Use:
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.
When Using:
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
Dosage and Administration:
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
Stop Use:
Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs. these may be signs of a serious condition
Package Label Principal Display Panel:
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) 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) 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) 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) 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) 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) dyna-hex 8-oz page 1 dyna-hex 8-oz page 2 dyna-hex 8-oz page 3 dyna-hex 8-oz page 4 dyna-hex 16-oz page 1 dyna-hex 16-oz pag 2 dyna-hex 16-oz page 3 dyna-hex 16-oz page 4 dyna-hex 32 page 1 dyna-hex 32 page 2 dyna-hex 32 page 3 dyna-hex 1-gal page 1 dyna-hex 1gal page 2 dyna-hex 1-gal page 3 dyna-hex 4 fm pdp dyna-hex 4 fm drug facts dyna-hex 4 fm drug facts 2 4dyn18 pdp 4dyn18 drug facts 1 4dyn18 drug facts 2
Further Questions:
Questions or comments? call 1-800-587-3721 monday through friday 8:00 am to 4:30 pm cst