Dr. Rainer S Vaginal Cream
Miconazole Nitrate
Plexoris Health Care Products, Llc
Human Otc Drug
NDC 73736-115Dr. Rainer S Vaginal Cream also known as Miconazole Nitrate is a human otc drug labeled by 'Plexoris Health Care Products, Llc'. National Drug Code (NDC) number for Dr. Rainer S Vaginal Cream is 73736-115. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Dr. Rainer S Vaginal Cream drug includes Miconazole Nitrate - 2 g/100mL . The currest status of Dr. Rainer S Vaginal Cream drug is Active.
Drug Information:
| Drug NDC: | 73736-115 |
| 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: | Dr. Rainer S Vaginal Cream |
| 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: | Miconazole Nitrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Plexoris Health Care Products, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | MICONAZOLE NITRATE - 2 g/100mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 23 Mar, 2020 |
| 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. |
| Application Number: | part333C |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Plexoris Health Care Products, Llc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 998540
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | VW4H1CYW1K
|
| 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. |
| Pharmacologic Class: | Azole Antifungal [EPC]
Azoles [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 73736-115-05 | 1 TUBE in 1 BOX (73736-115-05) / 28 mL in 1 TUBE | 23 Mar, 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 vaginal antifungal
Product Elements:
Dr. rainer s vaginal cream miconazole nitrate miconazole nitrate miconazole carbomer interpolymer type a (allyl sucrose crosslinked) aminomethylpropanol ethylhexylglycerin glycol stearate mineral oil peg-100 stearate phenoxyethanol propylene glycol stearic acid stearyl alcohol water
Indications and Usage:
Uses treats vaginal yeast infections
Warnings:
Warnings for vaginal use only do not use if you have never had a vaginal yeast infection diagnosed by a doctor. ask a doctor before use if you have vaginal itching and discomfort for the first time ⢠abdominal, back, shoulder pain, fever, chills, nausea, vomiting, foul smelling discharge ⢠if you are pregnant or have diabetes ⢠been exposed to the human immunodeficiency virus (hiv) that causes aids ask a doctor if you are taking prescription blood thinning medicine such as warfarin because bleeding or bruising may occur when using this product do not use tampons, douches, spermicides, or other vaginal products ⢠mild vaginal irritation may occur ⢠condoms and diaphragms may become damaged and fail to prevent pregnancy or sexually transmitted diseases ⢠if you do not get complete relief consult your doctor stop use and ask your doctor if symptoms do not get better in 7 days ⢠you get a rash, hives, abdominal pain, fever, chills, nausea, vomiting, or fo
Read more...ul smelling discharge ⢠if pregnant or breast feeding ask a doctor before using keep out of reach of children.
Dosage and Administration:
Directions for use by adults and children 12 years of age and older ⢠apply a small amount of cream to your finger tip ⢠apply to the outside and inside of the vagina before bedtime ⢠can be applied as many times as needed daily.
Package Label Principal Display Panel:
Packaging untitled