Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a28b1c33-d21e-493f-9978-54aba9a9c436
Route
TOPICAL
Published
Effective Date 2014-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Bentonite Jojoba Oil Magnesium Oxide Peppermint Oil Sage Oil Silver Oxide Tea Tree Oil White Wax Zinc Oxide Coconut Oil Glycerin Lauric Acid Lavender Oil Olive Oil Palm Acid Palm Kernel Acid Pentasodium Pentetate Propylene Glycol Sodium Stearate Shea Butter Sodium Laureth Sulfate Stearic Acid Sodium Chloride Sodium Palmate Sodium Palm Kernelate Sorbitol Titanium Dioxide Etidronate Tetrasodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-04-18

Description

Miconazole Nitrate 2%

Purpose

Vaginal Antifungal


Medication Information

Purpose

Vaginal Antifungal

Description

Miconazole Nitrate 2%

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

● lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling

vaginal discharge. You may have a more serious condition.

● vaginal yeast infections often (such as once a month or 3 in 6 months).

You could be pregnant or have a serious underlying medical cause for your

symptoms, including diabetes or a weakened immune system.

● been exposed to human immunedeficiency virus (HIV) that causes AIDS.

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine

warfarin, because bleeding or bruising may occur.

When using this product

● do not use tampons, douches, spermicides, or other vaginal products.

Condoms and diaphragms may be damaged and fail to prevent pregnancy

or sexually transmitted disease (STDs).

● do not have vaginal intercourse

● mild increase in vaginal burning, itching, or irritation may occur

● if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

● symptoms do not get better after 3 days

● symptoms last more than 7 days

● you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.



If pregnant or breast feeding, ask a health professional before use.

Directions

Children under 12: Ask a doctor.

Adults and children 12 years and over:

Ointment: May be used topically (outside the vaginal area) or intravaginally.

Squeeze a small amount of ointment onto fingertip.

Apply 2-3 times daily for up to 3 days or longer, as needed. May stain fabrics.

Cleansing Bar: Wash affected areadaily. Store at room temperature.

Active Ingredient

Miconazole Nitrate 2%

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel Box

Vaginal Discomfort

  • Vaginal Itch
  • Odor and Discharge
  • Yeast Infection and Vaginitis

All Natural

terrasil

RAPID-RELIEF VAGINAL OINTMENT

Plus Medicated Cleansing Bar

2.5X FASTER

compared to leading brands

in scientific studies

THE END OF SUFFERING

Healing and Relief Since 2004

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Treats vaginal yeast infections.

Purpose

Vaginal Antifungal

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

● lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling

vaginal discharge. You may have a more serious condition.

● vaginal yeast infections often (such as once a month or 3 in 6 months).

You could be pregnant or have a serious underlying medical cause for your

symptoms, including diabetes or a weakened immune system.

● been exposed to human immunedeficiency virus (HIV) that causes AIDS.

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine

warfarin, because bleeding or bruising may occur.

When using this product

● do not use tampons, douches, spermicides, or other vaginal products.

Condoms and diaphragms may be damaged and fail to prevent pregnancy

or sexually transmitted disease (STDs).

● do not have vaginal intercourse

● mild increase in vaginal burning, itching, or irritation may occur

● if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

● symptoms do not get better after 3 days

● symptoms last more than 7 days

● you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.



If pregnant or breast feeding, ask a health professional before use.

Directions

Children under 12: Ask a doctor.

Adults and children 12 years and over:

Ointment: May be used topically (outside the vaginal area) or intravaginally.

Squeeze a small amount of ointment onto fingertip.

Apply 2-3 times daily for up to 3 days or longer, as needed. May stain fabrics.

Cleansing Bar: Wash affected areadaily. Store at room temperature.

Active Ingredient

Miconazole Nitrate 2%

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel Box (PRINCIPAL DISPLAY PANEL - BOX)

Vaginal Discomfort

  • Vaginal Itch
  • Odor and Discharge
  • Yeast Infection and Vaginitis

All Natural

terrasil

RAPID-RELIEF VAGINAL OINTMENT

Plus Medicated Cleansing Bar

2.5X FASTER

compared to leading brands

in scientific studies

THE END OF SUFFERING

Healing and Relief Since 2004

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


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