Bactoshield Chg
Chlorhexidine Gluconate
Sc Johnson Professional Usa, Inc.
Human Otc Drug
NDC 11084-126Bactoshield Chg also known as Chlorhexidine Gluconate is a human otc drug labeled by 'Sc Johnson Professional Usa, Inc.'. National Drug Code (NDC) number for Bactoshield Chg is 11084-126. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Bactoshield Chg drug includes Chlorhexidine Gluconate - 20 mg/mL . The currest status of Bactoshield Chg drug is Active.
Drug Information:
| Drug NDC: | 11084-126 |
| 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: | Bactoshield Chg |
| 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: | Sc Johnson Professional Usa, 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 - 20 mg/mL
|
| 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: | 15 Nov, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| 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: | NDA019258 |
| 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: | 23 Dec, 2025 |
| 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: | SC Johnson Professional USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1245230
2196992
|
| 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 |
|---|
| 11084-126-03 | 118 mL in 1 BOTTLE (11084-126-03) | 15 Nov, 2019 | 31 Dec, 2023 | No |
| 11084-126-08 | 3785 mL in 1 BOTTLE (11084-126-08) | 15 Nov, 2019 | 31 Dec, 2023 | No |
| 11084-126-24 | 946 mL in 1 BOTTLE (11084-126-24) | 15 Nov, 2019 | 31 Dec, 2023 | No |
| 11084-126-41 | 1000 mL in 1 BOTTLE (11084-126-41) | 15 Nov, 2019 | 31 Dec, 2023 | 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:
Purposes surgical hand scrub healthcare personnel handwash skin wound and general skin cleanser
Product Elements:
Bactoshield chg chlorhexidine gluconate chlorhexidine gluconate chlorhexidine water coco diethanolamide cocamine oxide gluconic acid gluconolactone hydroxyethyl cellulose (5000 mpa.s at 1%) isopropyl alcohol peg-75 lanolin peg-150 distearate propylene glycol quaternium-33
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: handwash to help reduce bacteria that potentially can cause disease skin wound and general skin cleanser: helps reduce bacteria on the skin
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 are allergic to chlorhexidine gluconate or any other ingredient in this preparation as a patient preoperative skin preparation (especially on the head or face) in contact with meninges in the genital area 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 contact occurs, rinse with cold water right away 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 an underlying condition makes it necessary to
Read more...reduce the bacterial population of the skin stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. 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 are allergic to chlorhexidine gluconate or any other ingredient in this preparation as a patient preoperative skin preparation (especially on the head or face) in contact with meninges in the genital area 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 contact occurs, rinse with cold water right away 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 an underlying condition makes it necessary to reduce the bacterial population of the skin stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. 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 placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if contact occurs, rinse with cold water right away 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 an underlying condition makes it necessary to reduce the bacterial population of the skin
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. use full strength do not dilute surgical hand scrub remove jewelry wet hands and forearms with water and apply 5 ml of the product wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces rinse thoroughly with water wash for an additional 3 minutes with 5 ml of the 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 30 seconds rinse and dry thoroughly skin wound and general skin cleanser thoroughly rinse the area to be cleansed with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently. rinse thoroughly with water. rinse again thoroughly
Stop Use:
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. these may be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - 946 ml bottle label scj professional a family company⢠bactoshield ® chg 2% ndc 11084-126-24 surgical scrub chlorhexidine gluconate 2% solution antiseptic surgical scrub 2% chg antimicrobial net contents: 946ml (32 fl oz) 1322-21k(419) pat. www.scjp.com/patents sap # 4000000062 reorder # 1322-24 deb skin care principal display panel - 946 ml bottle label
Further Questions:
Questions or comments? call 1-866-783-0422 monday through friday 8:00 am to 5:00 pm est