Calendula Cream
Calendula Officinalis
Seroyal Usa
Human Otc Drug
NDC 62106-1177Calendula Cream also known as Calendula Officinalis is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Calendula Cream is 62106-1177. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Calendula Cream drug includes Calendula Officinalis Flowering Top - 1 [hp_X]/40g . The currest status of Calendula Cream drug is Active.
Drug Information:
| Drug NDC: | 62106-1177 |
| 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: | Calendula Cream |
| 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: | Seroyal Usa |
| 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 [hp_X]/40g
|
| 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: | 20 Jan, 2015 |
| 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, 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: | Seroyal USA
|
| 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: | 0883196316403
0883196316304
|
| UPC stands for Universal Product Code. |
| UNII: | O80TY208ZW
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 |
|---|
| 62106-1177-0 | 1 TUBE in 1 CARTON (62106-1177-0) / 40 g in 1 TUBE | 20 Jan, 2015 | 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:
Uses for the temporary relief of symptoms associated with minor cuts and burns
Uses for the temporary relief of symptoms associated with minor sprains and bruises.
Product Elements:
Calendula cream calendula officinalis glycerin cetostearyl alcohol calendula officinalis flowering top calendula officinalis flowering top water rose oil arnica cream arnica montana arnica montana arnica montana calendula officinalis flowering top calendula officinalis flowering top cetostearyl alcohol glycerin water
Indications and Usage:
Uses for the temporary relief of symptoms associated with minor cuts and burns directions adults: apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. children: use under the direction of your healthcare practitioner.
Uses for the temporary relief of symptoms associated with minor sprains and bruises. directions adults: apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. children: use under the direction of your healthcare practitioner.
Warnings:
Warnings for external use only. stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. do not use on irritated skin if excessive irritation develops when using this product, avoid getting into eyes or mucous membranes. stop use and ask a doctor if symptoms persist or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults: apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. children: use under the direction of your healthcare practitioner.
Directions adults: apply a small amount on the affected area two to three times daily, or as recommended by your healthcare practitioner. children: use under the direction of your healthcare practitioner.
Overdosage:
If swallowed, get medical help or contact a poison control center right away.
If swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Ndc 62106-1177-0 unda topicals calendula cream homeopathic preparation for the temporary relief of symptoms associated with minor cuts and burns. net weight 1.4 oz (40 g) 62106-1177-0
Ndc 62106-1180-0 unda topicals arnica cream homeopathic preparation for the temporary relief of symptoms associated with minor sprains and bruises. net weight 1.4 oz. (40 g) arnica cream