Label: DR. RAINER S VAGINAL CREAM- miconazole nitrate cream

  • NDC Code(s): 73736-115-05
  • Packager: Plexoris Health Care Products, Llc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Miconazole Nitrate 2%

  • PURPOSE

    Purpose

    Vaginal antifungal

  • INDICATIONS & 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 foul smelling discharge • If pregnant or breast feeding ask a doctor before using

    Keep out of reach of children.

  • DOSAGE & 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.

  • STORAGE AND HANDLING

    Other information store at room temperature, 68° to 77°F (20° to 25°C)

  • INACTIVE INGREDIENT

    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

  • SPL UNCLASSIFIED SECTION

    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.

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    DR. RAINER S VAGINAL CREAM 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73736-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73736-115-051 in 1 BOX03/23/2020
    128 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/23/2020
    Labeler - Plexoris Health Care Products, Llc (878415905)