Femiclear Bacterial Vaginosis Symptoms
Thymol With Olive Extract
Organicare Nature's Science, Llc
Human Otc Drug
NDC 71042-025Femiclear Bacterial Vaginosis Symptoms also known as Thymol With Olive Extract is a human otc drug labeled by 'Organicare Nature's Science, Llc'. National Drug Code (NDC) number for Femiclear Bacterial Vaginosis Symptoms is 71042-025. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Femiclear Bacterial Vaginosis Symptoms drug includes Olea Europaea Fruit Volatile Oil - 3 [hp_X]/100g Thymol - 6 [hp_X]/100g . The currest status of Femiclear Bacterial Vaginosis Symptoms drug is Active.
Drug Information:
| Drug NDC: | 71042-025 |
| 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 Bacterial Vaginosis Symptoms |
| 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: | Thymol With 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: | OLEA EUROPAEA FRUIT VOLATILE OIL - 3 [hp_X]/100g
THYMOL - 6 [hp_X]/100g
|
| 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 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 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: | 8E7358CX1J
3J50XA376E
|
| 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 |
|---|
| 71042-025-14 | 1 TUBE in 1 CARTON (71042-025-14) / 14.2 g in 1 TUBE | 01 Jun, 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 anti-bacterial agent anti-microbial and healing agent
Product Elements:
Femiclear bacterial vaginosis symptoms thymol with olive extract yellow wax olive oil thymol thymol olea europaea fruit volatile oil oleuropein
Indications and Usage:
Uses this product is intended to relieve symptoms associated with known bacterial vaginosis infecions, including fishy odor, excess discharge, irritation and burning while urinating.
Warnings:
Warnings for vaginal use only. do not use if you have never had a bacterial vaginosis infection diagnosed by a doctor. ointment may damage condoms and diaphragms and cause them to fail.
Ask a doctor before use if you have: vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. you may have a more serious condition. bacterial vaginosis often (such as once a month or 3 in 6 months). you could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (hiv) that causes aids.
Do Not Use:
Warnings for vaginal use only. do not use if you have never had a bacterial vaginosis infection diagnosed by a doctor. ointment may damage condoms and diaphragms and cause them to fail.
Ask a doctor before use if you have: vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. you may have a more serious condition. bacterial vaginosis often (such as once a month or 3 in 6 months). you could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (hiv) that causes aids.
When Using:
When using this product do not use tampons, douches, 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 relief, consult a doctor
Dosage and Administration:
Directions adults and children 12 years of age and older: use at bed time, read enclosed instructions for complete directions. to protect clothes, use a panty liner. fill applicator with vaginal ointment - use 1/2 of the tube lie down in bed. insert applicator into vagina and inject ointment. remain lying down to avoid leakage. discard applicator after use. do not reuse. repeat on second night - use other 1/2 of the tube children under 12 years : ask a doctor
Stop Use:
Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea or vomiting
Package Label Principal Display Panel:
Femiclear® bacterial vaginosis symptoms 90% reported a reduction in fishy odor itching excess discharge made with organic ingredients kills 99.9% of bacteria causing bv gardnerella vaginalis homeopathic medicine femiclear bv
Further Questions:
Questions? call 512.401.3572 or visit femiclear.com made and distributed by organicare, llc austin, tx 78744, usa