NDC 70403-925 Clotrimazole Antifungal

  1. Labeler Index
  2. Aru Pharma Inc.
  3. NDC: 70403-925 Clotrimazole Antifungal

NDC Product Code 70403-925

NDC CODE: 70403-925

Proprietary Name: Clotrimazole Antifungal What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 70403 - Aru Pharma Inc.

NDC 70403-925-30

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Clotrimazole Antifungal with NDC 70403-925 is a product labeled by Aru Pharma Inc.. The generic name of Clotrimazole Antifungal is . The product's dosage form is and is administered via form.

Labeler Name: Aru Pharma Inc.

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.
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETETH-20 (UNII: I835H2IHHX)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • CHLOROCRESOL (UNII: 36W53O7109)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Aru Pharma Inc.
Labeler Code: 70403
Start Marketing Date: 01-01-2018 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: 12-31-2020 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: I 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.

Clotrimazole Antifungal Product Label Images

Clotrimazole Antifungal 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

Active Ingredient

Clotrimazole USP 1%

Purpose

Antifungal

Uses

  • Cures most athlete's foot, jock itch and ringwormrelieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use onlyDo not use on children under 2 years of age unless directed by a doctorWhen using this product avoid contact with the eyesStop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

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. (1-800-222-1222)

Directions

  • Wash the affected area and dry thoroughlyapply a thin layer over affected area twice daily (morning and night)supervise children in the use of this productfor athlete's foot pay special attention to the spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water

Other Information

• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal• store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

* Please review the disclaimer below.