Dr. Rainer's Vaginal Cream

Dr. Rainer's Vaginal Cream
SPL v3
SPL
SPL Set ID 1f0ee635-c70d-4194-a01d-370ca5c22fcd
Route
TOPICAL
Published
Effective Date 2020-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol Ethylhexylglycerin Glycol Stearate Mineral Oil Peg-100 Stearate Phenoxyethanol Propylene Glycol Stearic Acid Stearyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-23

Description

Active ingredient Miconazole Nitrate 2%


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses Treats Vaginal Yeast Infections

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.

Description

Active ingredient Miconazole Nitrate 2%

Section 42229-5

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.

Section 44425-7

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

Section 50565-1

Keep out of reach of children.

Section 51727-6

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

Section 55105-1

Purpose

Vaginal antifungal

Section 55106-9

Active ingredient

Miconazole Nitrate 2%

Packaging

Drug Facts


Structured Label Content

Indications and Usage (34067-9)

Uses Treats Vaginal Yeast Infections

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

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.

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Purpose

Vaginal antifungal

Section 55106-9 (55106-9)

Active ingredient

Miconazole Nitrate 2%

Packaging

Drug Facts


Advanced Ingredient Data


Raw Label Data

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