Domeboro
Aluminum Acetate
Advantice Health, Llc.
Human Otc Drug
NDC 16864-250Domeboro also known as Aluminum Acetate is a human otc drug labeled by 'Advantice Health, Llc.'. National Drug Code (NDC) number for Domeboro is 16864-250. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Domeboro drug includes Aluminum Acetate - .5 g/100g . The currest status of Domeboro drug is Active.
Drug Information:
| Drug NDC: | 16864-250 |
| 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: | Domeboro |
| 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: | Aluminum Acetate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Advantice Health, Llc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | ALUMINUM ACETATE - .5 g/100g
|
| 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: | OTC MONOGRAPH 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: | 15 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 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: | part347 |
| 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: | 07 May, 2026 |
| 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: | Advantice Health, LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1739791
2360634
|
| 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: | 80EHD8I43D
|
| 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 |
|---|
| 16864-250-01 | 1 TUBE in 1 CARTON (16864-250-01) / 85 g in 1 TUBE | 15 Apr, 2020 | 31 Mar, 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:
Purpose astringent
Product Elements:
Domeboro aluminum acetate aluminum acetate aluminum cation boric acid alcohol glycerin hydrochloric acid hypromellose, unspecified menthol, unspecified form polysorbate 20 propylene glycol water
Indications and Usage:
Uses temporarily relieves minor skin irritations due to: poison ivy poison oak poison sumac insect bite athlete's foot rashes caused by soaps, detergents, cosmetics, or jewelry
Warnings:
Warnings for external use only when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days 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 avoid contact with eyes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions use only as directed apply liberally to the affected area as needed or as directed by a doctor. repeat three times a day or as directed by a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days
Package Label Principal Display Panel:
Principal display panel - 85 g tube carton doctor recommended domeboro ® aluminum acetate 0.5% - astringent burrow's solution relief since 1958 maximum strength cooling gel complete rash relief for rashes caused by poison ivy, oak, sumac & skin irritants relieves itch cooling relief in seconds plus dries oozing rashes reduces redness no mess, hands-free application net wt 3 oz (85g) principal display panel - 85 g tube carton
Further Questions:
Questions or comments call (800) 345-0032 or visit www.domeboro.com