NDC 50090-0614 Clotrimazole

NDC Product Code 50090-0614

NDC 50090-0614-0

Package Description: 1 TUBE in 1 CARTON > 45 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

Clotrimazole with NDC 50090-0614 is a product labeled by A-s Medication Solutions. The generic name of Clotrimazole is . The product's dosage form is and is administered via form.

Labeler Name: A-s Medication Solutions

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: A-s Medication Solutions
Labeler Code: 50090
Start Marketing Date: 12-04-1995 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: E What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Clotrimazole

Clotrimazole is pronounced as (kloe trim' a zole)

Why is clotrimazole medication prescribed?
Clotrimazole is used to treat yeast infections of the vagina, mouth, and skin such as athlete's foot, jock itch, and body ringworm. It can also be used to prevent oral th...
[Read More]

* Please review the disclaimer below.

Clotrimazole Product Label Images

Clotrimazole Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed by:Taro PharmaceuticalsU.S.A., Inc.Hawthorne, NY 10532

Otc - Purpose

Active ingredientsPurposeClotrimazole USP 1% (50 mg in each applicatorful)Vaginal AntifungalClotrimazole USP 1% (external cream)Vaginal Antifungal

Uses

  • Treats vaginal yeast infectionsrelieves external itching and irritation due to a vaginal yeast infection

Warnings

For vaginal use only

Otc - Do Not Use

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 timelower 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 diseases (STDs).do not have vaginal intercoursemild increase in vaginal burning, itching or irritation may occurif 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 in 3 dayssymptoms last more than 7 daysyou get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

  • Before using this product read the enclosed educational brochure for complete directions and informationadults and children 12 years of age and over:vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.children under 12 years of age: ask a doctor

Other Information

  • To open: unscrew cap, use pointed end on cap to puncture sealdo not use if carton is openedsafety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.store between 20° to 25°C (68° to 77°F)see flap of carton or crimp of tube for lot number and expiration date

Inactive Ingredients

Benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, and sorbitan monostearate

How Supplied

Product: 50090-0614NDC: 50090-0614-0 45 g in a TUBE

* Please review the disclaimer below.