Biophresh
Kreosotum 6c, Nitricum Acidum 6c, Thuja Occidentalis 6c, Pulsatilla Vulgaris 6c, Sepia Officinalis 6c
Good Clean Love, Inc.
Human Otc Drug
NDC 73716-001Biophresh also known as Kreosotum 6c, Nitricum Acidum 6c, Thuja Occidentalis 6c, Pulsatilla Vulgaris 6c, Sepia Officinalis 6c is a human otc drug labeled by 'Good Clean Love, Inc.'. National Drug Code (NDC) number for Biophresh is 73716-001. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Biophresh drug includes Nitric Acid - 6 [hp_C]/g Pulsatilla Vulgaris - 6 [hp_C]/g Sepia Officinalis Whole - 6 [hp_C]/g Thuja Occidentalis Leafy Twig - 6 [hp_C]/g Wood Creosote - 6 [hp_C]/g . The currest status of Biophresh drug is Active.
Drug Information:
| Drug NDC: | 73716-001 |
| 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: | Biophresh |
| 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: | Kreosotum 6c, Nitricum Acidum 6c, Thuja Occidentalis 6c, Pulsatilla Vulgaris 6c, Sepia Officinalis 6c |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Good Clean Love, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| 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: | NITRIC ACID - 6 [hp_C]/g
PULSATILLA VULGARIS - 6 [hp_C]/g
SEPIA OFFICINALIS WHOLE - 6 [hp_C]/g
THUJA OCCIDENTALIS LEAFY TWIG - 6 [hp_C]/g
WOOD CREOSOTE - 6 [hp_C]/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | 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: | 17 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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, 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: | Good Clean Love, Inc.
|
| 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: | 411VRN1TV4
I76KB35JEV
48GD5780QF
1NT28V9397
3JYG22FD73
|
| 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 |
|---|
| 73716-001-10 | 1 g in 1 BLISTER PACK (73716-001-10) | 17 Apr, 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:
Kreosotum 6c hpus* nitricum acidum 6c hpus*................vaginal itching and irritation thuja occidentalis 6c hpus* pulsatilla pratensis 6c hpus*................vaginal odor sepia officinalis 6c hpus*................vaginal discharge *"hpus" indicates the active ingredients are in the official homeopathic pharmacopeia of the united states.
Product Elements:
Biophresh kreosotum 6c, nitricum acidum 6c, thuja occidentalis 6c, pulsatilla vulgaris 6c, sepia officinalis 6c starch, tapioca lactobacillus plantarum lactobacillus rhamnosus maltodextrin lactobacillus gasseri lactobacillus reuteri lactobacillus salivarius ascorbic acid gelatin lactobacillus acidophilus lactobacillus crispatus thuja occidentalis leafy twig thuja occidentalis leafy twig pulsatilla vulgaris pulsatilla vulgaris sepia officinalis whole sepia officinalis whole wood creosote wood creosote nitric acid nitric acid
Indications and Usage:
Uses for the temporary relief of symptoms of bacterial vaginosis due to bacterial imbalance in the vagina including unusual vaginal odor, itching, irritaiton, or abnormal discharge. claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.
Warnings:
For vaginal use only do not use with other vaginal suppositories during menstruation or with use of a tampon 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. been exposed to the human immunodeficiency virus (hiv) that causes aids or any other sexually transmitted disease. stop use and ask doctor if symptoms do not get better in 7 days symptoms last more than 14 days you ge a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul smelling vaginal discharge if pregnant, trying to conceive, or breastfeeding consult your doctor before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
For vaginal use only do not use with other vaginal suppositories during menstruation or with use of a tampon 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. been exposed to the human immunodeficiency virus (hiv) that causes aids or any other sexually transmitted disease. stop use and ask doctor if symptoms do not get better in 7 days symptoms last more than 14 days you ge a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul smelling vaginal discharge if pregnant, trying to conceive, or breastfeeding consult your doctor before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
Dosage and Administration:
Directions wash hands before use when the vaginal area is clean and dry, use either your finger or providede applicator to insert capsule as far as is comfortable adults 18 years of age and over: insert one suppository into the vagina every 3 days as needed before bedtime to relieve symptoms of bacterial vaginosis and to support vaginal flora. under 18 years of age: consult a doctor
Stop Use:
Stop use and ask doctor if symptoms do not get better in 7 days symptoms last more than 14 days you ge a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul smelling vaginal discharge
Package Label Principal Display Panel:
Good clean love biophresh vaginal homeopathic suppositor helps relieve symptoms of bacterial vaginosis bio-match technology works the way you do. 10 gelatin suppositories 1 2
Further Questions:
Questions or comments? 1-541-344-4483 monday through friday, 9 a.m. - 5 p.m. pst or visit our website at www.goodcleanlove.com. you may also report serious side effects to this phone number.