Femiclear Yeast Infection Treatment
Calendula, Melaleuca, Oleuropein, Chamomilla
Organicare Nature's Science, Llc
Human Otc Drug
NDC 71042-011Femiclear Yeast Infection Treatment also known as Calendula, Melaleuca, Oleuropein, Chamomilla is a human otc drug labeled by 'Organicare Nature's Science, Llc'. National Drug Code (NDC) number for Femiclear Yeast Infection Treatment is 71042-011. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Femiclear Yeast Infection Treatment drug includes . The currest status of Femiclear Yeast Infection Treatment drug is Active.
Drug Information:
| Drug NDC: | 71042-011 |
| 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 Yeast Infection Treatment |
| 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: | Yeast Infection Treatment |
| 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: | Calendula, Melaleuca, Oleuropein, Chamomilla |
| 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: | 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
VAGINAL
|
| 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: | 12 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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, 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: | |
| 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 |
|---|
| 71042-011-28 | 1 KIT in 1 CARTON (71042-011-28) * 14 g in 1 TUBE (71042-013-14) * 14 g in 1 TUBE (71042-012-14) | 12 Nov, 2021 | 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:
Purposes healing agent anti-yeast agent antimicrobial and healing agent anti-itch and inflammatory agent anti-microbial and healing agent
Product Elements:
Femiclear yeast infection treatment calendula, melaleuca, oleuropein, chamomilla femiclear vaginal calendula, melaleuca, oleuropein olive oil lavender oil yellow wax calendula officinalis flowering top calendula officinalis flowering top oleuropein oleuropein melaleuca cajuputi leaf oil melaleuca cajuputi leaf oil femiclear external anti-itch chamomilla, oleuropein lavender oil olive oil oatmeal yellow wax oleuropein oleuropein matricaria chamomilla matricaria chamomilla
Indications and Usage:
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Warnings:
Warnings for vaginal use only. do not use if you have never had a vaginal yeast infection diagnosed by a doctor. femiclear may damage condoms and diaphragms and cause them to fail.
Do Not Use:
Warnings for vaginal use only. do not use if you have never had a vaginal yeast infection diagnosed by a doctor. femiclear may damage condoms and diaphragms and cause them to fail.
When Using:
When using this product do not use tampons, douiches, spermicides, or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted infections (stis) do not have vaginal intercourse mild increase in vaginal burning, itching, or irritation may occur if you do not get complete relief, ask a doctor before using another product
Dosage and Administration:
Directions adults and children 12 years or over: âvaginal ointment: use at bedtime, read enclosed instructions for complete directions. to protect clothes, use panty liner fill applicator with femiclear vaginal ointment (pink tube). lie down in bed. insert applicator into vagina and inject femiclear. remain lying down to avoid leakage. discard applicator after use. do not reuse. repeat on second night. itch relief: squeeze ointment onto fingertips. apply onto itchy, irritated skin outside the vagina (vulva) as needed. children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if symptoms do not improve in 3 days symptoms remain after 7 days you get abdominal pain, fever, chills, vomiting, foul-smelling discharge, or hives
Package Label Principal Display Panel:
Femiclear kit nov 2021 pdp
Further Questions:
Questions? call 512-401-3572 or visit femiclear.com organicare, llc, austin, tx 78744, usa