Califlora Calendula Gel
Calendula Officinalis Flowering Top
Schwabe Mexico S.a. De D.v
Human Otc Drug
NDC 68466-0007Califlora Calendula Gel also known as Calendula Officinalis Flowering Top is a human otc drug labeled by 'Schwabe Mexico S.a. De D.v'. National Drug Code (NDC) number for Califlora Calendula Gel is 68466-0007. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Califlora Calendula Gel drug includes Calendula Officinalis Flowering Top - 1 [hp_X]/78g . The currest status of Califlora Calendula Gel drug is Active.
Drug Information:
| Drug NDC: | 68466-0007 |
| 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: | Califlora Calendula Gel |
| 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 Flowering Top |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Schwabe Mexico S.a. De D.v |
| 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: | CALENDULA OFFICINALIS FLOWERING TOP - 1 [hp_X]/78g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
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: | 01 Jan, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2025 |
| 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: | 25 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: | Schwabe Mexico S.A. de D.V
|
| 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: | 0308078251974
|
| 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 |
|---|
| 68466-0007-4 | 1 TUBE in 1 CARTON (68466-0007-4) / 28 g in 1 TUBE | 01 Jan, 2006 | 31 Jul, 2023 | No |
| 68466-0007-8 | 1 TUBE in 1 CARTON (68466-0007-8) / 78 g in 1 TUBE | 01 Jan, 2006 | 31 Mar, 2025 | 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 temporarily relieves pain and itch associated with sunburn, windburn and chapped skin. helps promote healing of minor burns and skin irritations.
Product Elements:
Califlora calendula gel calendula officinalis flowering top calendula officinalis flowering top calendula officinalis flowering top carbomer homopolymer type c alcohol water sodium hydroxide witch hazel
Indications and Usage:
Indications & usage temporarily relieves pain and itch associated with sunburn, windburn and chapped skin. helps promote healing of minor burns and skin irritations.
Warnings:
Warning for external use only: avoid contact with eyes.
Do Not Use:
Warning for external use only: avoid contact with eyes.
Dosage and Administration:
Dosage & administration directions: apply thin layer to affected area. for best results, use promptly after injury or tramua occurs. for minor burns, first run cool water on the burn area and dry. for minor skin irritation, first wash the area with mild soap, rinse and dry. adults and children 2 years of age and older: apply to affected area. repeat as necessary. children under 2 years of age: consult a doctor patch test recommended on sensitive skin.
Overdosage:
Overdose if swallowed, seek medical help or contact a poison control center immediately.
Package Label Principal Display Panel:
Lbn21825197.a01-califlora gel.jpg