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Product NDC Code | 73736-115 | ||||
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Drug Name | Dr. rainer s vaginal cream |
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Type | Brand | ||||
Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 998540 | ||||
Application Number | part333C | ||||
Labeler Name | Plexoris Health Care Products, Llc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Miconazole Nitrate 2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Ethylhexylglycerin, Glycol Stearate, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Treats Vaginal Yeast Infections
Purpose
Information about the drug product’s indications for use.Purpose Vaginal antifungal
Spl product data elements
Usually a list of ingredients in a drug product.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
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging untitled
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
antifungal moisturizer for yeast infections Gynecologist recommended Supplements the body’s natural lubrication Long lasting relief Cures most vaginal yeast infections Soothes irritation on ontact Helps relieve vaginal itching and burning Dr. Rainer’s vaginal cream is a mineral oil antifungal cream used to treat women that suffer from vaginal dryness, itching and pain associated with yeast infections that is safe to use everyday, multiple times. Keep this and all medications out of the reach of children. For vaginal use only. Distributed by: Harmony Preferred Products, LLC Kirkland WA 98033 All rights reserved. Made in USA. Dr. Rainer’s cream was specially created for the vaginal area as a mineral oil based antifungal cream used to treat women that suffer from vaginal dryness, itching, burning, irritation and pain associated with yeast infections. It is safe to use everyday, multiple times a day as needed. Both young and mature women alike may benefit from the daily use of Dr. Rainer’s cream.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature, 68° to 77°F (20° to 25°C)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 foul smelling discharge • If pregnant or breast feeding ask a doctor before using Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API