Femiclear Vaginal Itch Relief
Chamomilla, Olive Extract
Organicare Nature's Science, Llc
Human Otc Drug
NDC 71042-010Femiclear Vaginal Itch Relief also known as Chamomilla, Olive Extract is a human otc drug labeled by 'Organicare Nature's Science, Llc'. National Drug Code (NDC) number for Femiclear Vaginal Itch Relief is 71042-010. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Femiclear Vaginal Itch Relief drug includes Chamomile - 3 [hp_X]/14g Olea Europaea Fruit Volatile Oil - 2 [hp_X]/14g . The currest status of Femiclear Vaginal Itch Relief drug is Active.
Drug Information:
| Drug NDC: | 71042-010 |
| 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: | Femiclear Vaginal Itch Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Femiclear |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Vaginal Itch Relief |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Chamomilla, Olive Extract |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Organicare Nature's Science, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| 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: | CHAMOMILE - 3 [hp_X]/14g
OLEA EUROPAEA FRUIT VOLATILE OIL - 2 [hp_X]/14g
|
| 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 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Jun, 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: | Organicare Nature's Science, 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: | FGL3685T2X
8E7358CX1J
|
| 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 |
|---|
| 71042-010-14 | 1 TUBE in 1 CARTON (71042-010-14) / 14.2 g in 1 TUBE | 20 Feb, 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 anti-itch and anti-inflammatory agent antimicrobial and healing agent
Product Elements:
Femiclear vaginal itch relief chamomilla, olive extract oatmeal olive oil yellow wax chamomile chamomile olea europaea fruit volatile oil olea europaea fruit volatile oil
Indications and Usage:
Use temporarily relieves external feminine itching
Warnings:
Warnings for external use. femiclear may damage condoms and diaphragms and cause them to fail. do not use if you have a vaginal discharge. consult a doctor. if you are allergic to any of the ingredients when using this product avoid contact with the eyes stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days rash or other allergic reaction develops
Do Not Use:
Warnings for external use. femiclear may damage condoms and diaphragms and cause them to fail. do not use if you have a vaginal discharge. consult a doctor. if you are allergic to any of the ingredients when using this product avoid contact with the eyes stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days rash or other allergic reaction develops
When Using:
When using this product avoid contact with the eyes
Dosage and Administration:
Directions adults and children 12 years of age and older apply a fingertip amount to affected area as needed. children under 12 years consult a doctor
Stop Use:
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days rash or other allergic reaction develops
Package Label Principal Display Panel:
Made with organic ingredients no artificial chemicals or steroids maximum strength fast feminine itch relief ⦠itching ⦠burning ⦠irritation femiclear® vaginal itch relief homeopathic medicine net wt. 0.5 oz (14.2 g) femiclear oatmeal ver 3
Further Questions:
Questions? call 512.401.3572 or visit femiclear.com