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basic care tioconazole

tioconazole · basic care tioconazole is an azole antifungal (over-the-counter) containing tioconazole, made by Amazon.com Services LLC.

Type
Over the counter
Drug class
Azole Antifungal
Route
Vaginal
Manufacturers
1

• treats vaginal yeast infections

Drug facts

Generic name
tioconazole
Active ingredients
Tioconazole
Drug class
Azole Antifungal
Dosage forms
Ointment
Label holder
Amazon.com Services LLC
FDA application
ANDA075915
Label updated
12/18/2024

Active ingredients

(in each applicator) Tioconazole 300 mg (6.5%)

Purpose

Vaginal antifungal

Uses

  • Treats vaginal yeast infections

Directions

  • Before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information
  • Adults and children 12 years of age and over:
  • Open the printed packet just before use and remove purple cap
  • Insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
  • Children under 12 years of age: ask a doctor

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 the human immunodeficiency virus (HIV) that causes AIDS 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use

If you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use

  • 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 the human immunodeficiency virus (HIV) that causes AIDS

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

  • 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

Pregnancy or breastfeeding

Ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Other information

  • This product is a 1-dose treatment. Most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days.
  • If you have questions about vaginal yeast infections, consult your doctor
  • Store at 20 ° -25 ° C (68 ° -77 ° F)
  • See end flap of carton for lot number and expiration date

Inactive ingredients

Butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

Questions?

1-800-719-9260

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Ointment6.5 g/100gvaginal1

Manufacturers and labels

1 FDA label

  • Amazon.com Services LLCShown hereANDA075915 · Label 12/18/2024 · NDC 72288-426Full label

Related recalls

No FDA enforcement reports name basic care tioconazole or its active ingredient.

basic care tioconazole: common questions

What is basic care tioconazole used for?
• treats vaginal yeast infections
Is basic care tioconazole a prescription drug?
No. basic care tioconazole is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as basic care tioconazole?
Yes. Other FDA-listed products with the same active ingredients include Tioconazole 1, CareOne Tioconazole 1, Equaline Tioconazole 1, Equate tioconazole 1 day.
Who makes basic care tioconazole?
Amazon.com Services LLC lists basic care tioconazole with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/18/2024 · Label text is shown as published by the manufacturer. Not medical advice