Triderma Ulcer Defense Healing
Calendula Officinalis
Genuine Virgin Aloe Corporation
Human Otc Drug
NDC 10738-057Triderma Ulcer Defense Healing also known as Calendula Officinalis is a human otc drug labeled by 'Genuine Virgin Aloe Corporation'. National Drug Code (NDC) number for Triderma Ulcer Defense Healing is 10738-057. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Triderma Ulcer Defense Healing drug includes Calendula Officinalis Flowering Top - 1.5 g/100g . The currest status of Triderma Ulcer Defense Healing drug is Active.
Drug Information:
| Drug NDC: | 10738-057 |
| 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: | Triderma Ulcer Defense Healing |
| 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: | Calendula Officinalis |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Genuine Virgin Aloe Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | CALENDULA OFFICINALIS FLOWERING TOP - 1.5 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: | UNAPPROVED HOMEOPATHIC |
| 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: | 30 Aug, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | Genuine Virgin Aloe Corporation
|
| 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. |
| UPC: | 0182228000892
0818926010207
|
| UPC stands for Universal Product Code. |
| UNII: | 18E7415PXQ
|
| 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 |
|---|
| 10738-057-20 | 1 TUBE in 1 CARTON (10738-057-20) / 62 g in 1 TUBE (10738-057-25) | 30 Aug, 2019 | N/A | No |
| 10738-057-40 | 1 TUBE in 1 CARTON (10738-057-40) / 119 g in 1 TUBE (10738-057-45) | 30 Aug, 2019 | N/A | No |
| 10738-057-50 | 1 TUBE in 1 CARTON (10738-057-50) / 14 g in 1 TUBE (10738-057-55) | 30 Aug, 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 speed healing, minimizes recurrence, healing agent. hpus indicates that this ingredient is officially included in the homeopathic pharmacopeia of the united states.
Product Elements:
Triderma ulcer defense healing calendula officinalis water cetostearyl alcohol isopropyl palmitate polysorbate 60 yellow wax dimethicone allantoin zinc pidolate oatmeal aloe vera leaf shea butter .alpha.-tocopherol acetate panthenol cetyl alcohol sodium pyrrolidone carboxylate phytate sodium sodium hydroxide phenoxyethanol ethylhexylglycerin calendula officinalis flowering top calendula officinalis flowering top
Indications and Usage:
Uses ⢠speed healing of wounds, sores, acne and lip sores ⢠helps promote healing of cuts, scrapes, chafing, minor burns and sunburn
Warnings:
Warnings for external use only. avoid contact with eyes. intended for adults only. do not use if you are allergic to calendula officinalis or to this product's inactive ingredients. stop use and ask a doctor before use in case of deep puncture wounds, animal bites or serious burns and if condition persists for more than 4 days or worsens. keep out of reach of children. if swallowed, get medical help and contact a poison control center right away.
Dosage and Administration:
Directions â¢read all package directions and warnings before use. when using this product use only as directed. apply a thin layer to affected area and massage gently as soon as possible after minor injury. apply 3x a day or as needed. â¢sensitivity test for a new user. apply sparingly to one or two small affected areas during the first 7 days. â¢if no discomfort occurs, follow the direction stated above.
Package Label Principal Display Panel:
Packaging image
Packaging box
Packaging three
Packaging four
Packaging defense
Packaging seven
Further Questions:
Questions? 1-800-279-7282 m-f 8am-4pm pst