Scrub Care Exidine -4 Chg
Chlorhexidine Gluconate
Xttrium Laboratories, Inc.
Human Otc Drug
NDC 0116-2994Scrub Care Exidine -4 Chg also known as Chlorhexidine Gluconate is a human otc drug labeled by 'Xttrium Laboratories, Inc.'. National Drug Code (NDC) number for Scrub Care Exidine -4 Chg is 0116-2994. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Scrub Care Exidine -4 Chg drug includes Chlorhexidine Gluconate - 4 mg/100mL . The currest status of Scrub Care Exidine -4 Chg drug is Active.
Drug Information:
| Drug NDC: | 0116-2994 |
| 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: | Scrub Care Exidine -4 Chg |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Scrub Care |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Exidine -4 CHG |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Liquid |
| 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 mg/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: | 01 Nov, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| 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
1661076
|
| 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. |
| 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 |
|---|
| 0116-2994-01 | 3786 mL in 1 JUG (0116-2994-01) | 01 Nov, 2012 | N/A | No |
| 0116-2994-04 | 118 mL in 1 BOTTLE, PLASTIC (0116-2994-04) | 01 Nov, 2012 | N/A | No |
| 0116-2994-08 | 237 mL in 1 BOTTLE, PLASTIC (0116-2994-08) | 01 Nov, 2012 | N/A | No |
| 0116-2994-16 | 473 mL in 1 BOTTLE, PLASTIC (0116-2994-16) | 01 Nov, 2012 | N/A | No |
| 0116-2994-17 | 473 mL in 1 BOTTLE, PLASTIC (0116-2994-17) | 01 Nov, 2012 | N/A | No |
| 0116-2994-32 | 946 mL in 1 BOTTLE, PLASTIC (0116-2994-32) | 01 Nov, 2012 | N/A | No |
| 0116-2994-33 | 946 mL in 1 BOTTLE, PLASTIC (0116-2994-33) | 01 Nov, 2012 | 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:
Scrub care exidine -4 chg chlorhexidine gluconate lauramine oxide coco diethanolamide peg-75 lanolin hydroxyethyl cellulose (2000 cps at 1%) isopropyl alcohol water tridecyl alcohol gluconolactone chlorhexidine gluconate chlorhexidine
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 patient preoperatve skin preparation: for the preparation of the patient's skin prior to surgery 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 when using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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
Read more... provider
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 when using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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:
When using this product keep out of eyes, ears, and mouth. may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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
Dosage and Administration:
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 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 vigorous manner for about 15 seconds rinse and dry thoroughly patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel skin wound and general skin cleansing: thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessa
Read more...ry to cover the skin or wound area and wash gently rinse again thoroughly
Stop Use:
Stop use and ask a 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 0116-2994-04 ref 29900-404 bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic non-sterile solution contans: 4% chlorhexidine gluconate for external use only for single use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10096 rev. a 4cfb04btlble net contents: 4 fl oz (118 ml) ndc 0116-2994-05 bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic non-sterile solution contains: 4% chlorhxidine gluconate for external use only for single use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10081 rev. a etobtllble net contents: 4 fl oz (118 ml) ndc 0116-2994-08 ref 29900-408 bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic contains: 4% chlorhexidine gluconate for external use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10097 rev. a 4cf08btlble net contents: 8 fl oz (237 ml) ndc 0116-2994-16 ref 29900-416 bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic contains: 4% chlorhexidine gluconate for external use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10098 rev. a 4cfb16btllblc net contents: 16 fl oz (1 pt) (473 ml) ndc 0116-2994-17 ref 29900-416p bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic contains: 4% chlorhexidine gluconate for external use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10099 rev. a 4cfb16btlplblc net contents: 16 fl oz (1 pt) (473 ml) ndc 0116-2994-32 ref 29900-432 bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic contains: 4% chlorhexidine gluconate for external use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10100 rev. a 4cfb32btllblc net contents: 32 fl oz (1 qt) (946 ml) ndc 0116-2994-33 ref 29900-432p bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic contains: 4% chlorhexidine gluconate for external use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10101 rev. a 4cf32btlplblc net contents: 32 fl oz (1 qt) (946 ml) ndc 0116-2994-01 ref 29900-401 bd scrub care⢠exidineâ¢-4 chg 4% chlorhexidine gluconate 4% solution antiseptic contains: 4% chlorhexidine gluconate for external use only distributed by becton, dickinson and company vernon hills, il 60061 usa 51-10095 rev. a 4cf1gbtllbld net contents: 128 fl oz (1 gal) (3.8 l) 4cf04 pdp 4cf04 df1 4cf04 df2 4cf04 df3 4cf04 df4 4eto pdp 4cf08 pdp 4cf16 pdp 4cf16p pdp 4cf32 4cf32p 4cf1g pdp
Further Questions:
Questions or comments? call 1-800-587-3721 monday through friday 8:00 am to 4:30 pm cst