Frankincense And Myrrh
Intensive Foot Therapy Lotion
Wise Consumer Products Co.
Human Otc Drug
NDC 42346-519Frankincense And Myrrh also known as Intensive Foot Therapy Lotion is a human otc drug labeled by 'Wise Consumer Products Co.'. National Drug Code (NDC) number for Frankincense And Myrrh is 42346-519. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Frankincense And Myrrh drug includes Hypericum Perforatum - 3 [hp_X]/g . The currest status of Frankincense And Myrrh drug is Active.
Drug Information:
| Drug NDC: | 42346-519 |
| 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: | Frankincense And Myrrh |
| 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: | Intensive Foot Therapy Lotion |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wise Consumer Products Co. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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: | HYPERICUM PERFORATUM - 3 [hp_X]/g
|
| 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: | 01 Jul, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 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: | 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: | Wise Consumer Products Co.
|
| 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: | XK4IUX8MNB
|
| 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 |
|---|
| 42346-519-85 | 1 g in 1 CARTON (42346-519-85) | 01 Jul, 2020 | 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 hypericum perforatum 3x hpus.......topical analgesic
Product Elements:
Frankincense and myrrh intensive foot therapy lotion eucalyptus oil cinnamon leaf oil xanthan gum rosemary oil shea butter glycerin cetyl alcohol myrrh oil coconut oil geranium oil, algerian type methylparaben stearic acid lanolin sodium hydroxide menthol water medium-chain triglycerides cocoa butter peppermint oil citrus aurantium fruit oil nutmeg oil propylparaben frankincense oil lemon oil hypericum perforatum hypericum perforatum
Indications and Usage:
Uses for the temporary relief of minor aches and pains.
Warnings:
Warnings for external use only. do not use on wounds or damaged skin over large areas of the body
When Using:
When using this product avoid contact with the eyes do not bandage tightly
Dosage and Administration:
Directions adults and children 12 years of age and older : apply to affected area not more than 3 to 4 times daily. children under 12 years of age: consult a doctor.
Stop Use:
Stop use and ask a doctor if condition worsens if irritaion occurs if symptoms persist for more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Frankincense & myrrh intensive foot therapy lotion dual action temporary pain relief hydrating repair pain relieving topical lotion homeopathic net wt. 3oz (85g) 1
Further Questions:
Questions or comments? 1-877-917-9674 mon-fri. 9 a.m. - 5 p.m. est www.frankincensemyrrh.com