NDC 65373-100 Tineacide Physician Formula

NDC Product Code 65373-100

NDC 65373-100-01

Package Description: 35.4 g in 1 BOTTLE

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

NDC Product Information

Tineacide Physician Formula with NDC 65373-100 is a product labeled by Blaine Labs Inc.. The generic name of Tineacide Physician Formula is . The product's dosage form is and is administered via form.

Labeler Name: Blaine Labs 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.

  • WATER (UNII: 059QF0KO0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CLOTRIMAZOLE (UNII: G07GZ97H65)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
  • ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYOXYL 100 STEARATE (UNII: YD01N1999R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • UREA (UNII: 8W8T17847W)

Product Labeler Information

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

Labeler Name: Blaine Labs Inc.
Labeler Code: 65373
Start Marketing Date: 01-01-1995 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: 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.

Tineacide Physician Formula 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 Ingredients

Undecylenic Acid

Inactive Ingredients

Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, Lavender Oil, Methylparaben, PEG-100, Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water

Uses

Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

For effective relief of itching, cracking, burning and discomfort which can accompany these conditions.

Ask Your Physician

Do not use on children under 2 years of age unless directed by a physician

When Using This Product

Wash the affected area with soap and water and dry thoroughly.  Apply sparingly over affected area twice daily (morning and night) or as directed by a physician.  For athlete's foot pay special attention to spaces between the toes.  wear well-fitting ventilated shoes and change shoes and socks at least once daily.  For athlete's foot and ringworm use daily for 4 weeks.  for jock itch use daily for 2 weeks.  If condition persists longer, consult a physician.

Warnings

For external use only.  Avoid contact with eyes.  If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch) discontinue use and consult a physician.  Keep this and all drugs out of the reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

Tineacide Label

Tineacide Antifungal Cream  Physician FormulaDispensed by a physician only.

* Please review the disclaimer below.