DR. RAINER S VAGINAL CREAM- miconazole nitrate cream 
Plexoris Health Care Products, Llc

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.

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Dr. Rainer's Vaginal Cream

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Vaginal antifungal

Uses Treats Vaginal Yeast Infections

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.

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.

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

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

antifungal moisturizer for yeast infections

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

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)

Revised: 11/2021
Document Id: 25c19433-d7b3-479a-a02d-c7c6be293972
Set id: 1f0ee635-c70d-4194-a01d-370ca5c22fcd
Version: 2
Effective Time: 20211111
 
Plexoris Health Care Products, Llc