Dettol First Aid Antiseptic
Chloroxylenol
Reckitt Benckiser (uk) Ltd.
Human Otc Drug
NDC 52031-0876Dettol First Aid Antiseptic also known as Chloroxylenol is a human otc drug labeled by 'Reckitt Benckiser (uk) Ltd.'. National Drug Code (NDC) number for Dettol First Aid Antiseptic is 52031-0876. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Dettol First Aid Antiseptic drug includes Chloroxylenol - 4.8 g/15mL . The currest status of Dettol First Aid Antiseptic drug is Active.
Drug Information:
| Drug NDC: | 52031-0876 |
| 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: | Dettol First Aid Antiseptic |
| 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: | Chloroxylenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Reckitt Benckiser (uk) Ltd. |
| 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: | CHLOROXYLENOL - 4.8 g/15mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | CUTANEOUS
|
| 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: | OTC MONOGRAPH NOT FINAL |
| 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 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 Jun, 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: | part333A |
| 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: | Reckitt Benckiser (UK) Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 0F32U78V2Q
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52031-0876-2 | 250 mL in 1 BOTTLE (52031-0876-2) | 01 Sep, 2022 | N/A | No |
| 52031-0876-3 | 500 mL in 1 BOTTLE (52031-0876-3) | 01 Sep, 2022 | N/A | No |
| 52031-0876-4 | 750 mL in 1 BOTTLE (52031-0876-4) | 01 Sep, 2022 | 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 first aid antiseptic
Product Elements:
Dettol first aid antiseptic chloroxylenol chloroxylenol chloroxylenol caramel castor oil sodium hydroxide isopropyl alcohol white pine oil water 500 ml bottle front 500 ml bottle back
Indications and Usage:
Uses first aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings:
Warnings for external use only.
Do Not Use:
Warnings for external use only.
When Using:
First aid to help prevent infection of minocutsscrapesburns
When using this product if contact is made with eyes, wash thoroughly with cold water and consult your doctor.
Dosage and Administration:
Directions clean the affected area do not use undiluted apply a small amount of this product on the area 1 to 3 times daily for antiseptic treatment of minor cuts, burns and scrapes: dilute 1:20 in water if bandaged, let dry first
Stop Use:
Stop use and consult a doctor if the condition persists or gets worse. do not use longer than 1 week unless directed by a doctor.
Package Label Principal Display Panel:
Package label - principal display panel dettol liquid chloroxylenol 4.8% first aid antiseptic net wt.: 16.9 fl. oz. (500 ml) 3224889 dettol liquid chloroxylenol 4.8% first aid antiseptic net wt.16.9 fl. oz (500ml) www.rbnainfo.com dettol ® and the sword device are registered trademarks. reckitt manufacturer reckitt benckiser healthcare(uk) limited hull hu8 7ds +44 1482 326151 made in england 3224888
Further Questions:
Questions? 1-800-228-4722