Lip Balm 4pc Kit
Calendula Officinalis Flower
Sierra Sage Herbs Llc
Human Otc Drug
NDC 70994-406Lip Balm 4pc Kit also known as Calendula Officinalis Flower is a human otc drug labeled by 'Sierra Sage Herbs Llc'. National Drug Code (NDC) number for Lip Balm 4pc Kit is 70994-406. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Lip Balm 4pc Kit drug includes . The currest status of Lip Balm 4pc Kit drug is Active.
Drug Information:
| Drug NDC: | 70994-406 |
| 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: | Lip Balm 4pc Kit |
| 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 Flower |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sierra Sage Herbs Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| 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: | 04 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Sierra Sage Herbs LLC
|
| 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: | |
| 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 |
|---|
| 70994-406-12 | 1 KIT in 1 BOX (70994-406-12) | 04 Mar, 2022 | 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 section skin protectant
Product Elements:
Lip balm 4pc kit calendula officinalis flower unscented lip balm calendula officinalis flower calendula officinalis flower calendula officinalis flower alpha-tocopherol yellow wax sunflower oil coconut oil jojoba oil olive oil sweet honey lip balm zinc oxide, calendula officinalis flower orange oil olive oil sunflower oil zinc oxide zinc oxide calendula officinalis flower calendula officinalis flower alpha-tocopherol lemon oil yellow wax coconut oil jojoba oil citrus zest lip balm calendula officinalis flower calendula officinalis flower calendula officinalis flower alpha-tocopherol lemon oil yellow wax sunflower oil coconut oil jojoba oil orange oil olive oil cool mint lip balm calendula officinalis flower mentha piperita olive oil calendula officinalis flower calendula officinalis flower alpha-tocopherol yellow wax sunflower oil coconut oil jojoba oil
Indications and Usage:
Indications & usage section ⢠temporarily helps relieve ⢠chapped or cracked lips ⢠helps protect from the drying effects of wind and cold weather ⢠temporarily protects and helps relieve minor skin irritations due to ⢠chaffing ⢠redness ⢠windburn ⢠sun exposure ⢠temporarily helps moisturize ⢠chapped and cracked lips
Warnings:
Warnings section warnings for external use only. â do not use on â deep wounds â animal bites â serious burns â stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days â when using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Dosage & administration section apply as often as needed to affected area.
Package Label Principal Display Panel:
Principal display panel lip balm 4pc kit