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.
Updated March 23, 2020
If you are a consumer or patient please visit this version.
- Drug Facts
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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.
INGREDIENTS AND APPEARANCE
DR. RAINER S VAGINAL CREAM
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73736-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73736-115-05 1 in 1 BOX 03/23/2020 1 28 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/23/2020 Labeler - Plexoris Health Care Products, Llc (878415905)