NDC 69983-026 Fungablend 10

Tolnaftate

NDC Product Code 69983-026

NDC 69983-026-01

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

NDC Product Information

Fungablend 10 with NDC 69983-026 is a a human over the counter drug product labeled by Happy Foot Shop, Llc. The generic name of Fungablend 10 is tolnaftate. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Happy Foot Shop, Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Fungablend 10 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TOLNAFTATE 10 mg/mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • PUMMELO (UNII: ET1TN5W71X)
  • LEMON OIL (UNII: I9GRO824LL)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LAURETH-7 (UNII: Z95S6G8201)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • OREGANO LEAF OIL (UNII: 7D0CGR40U1)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • ROSEMARY (UNII: IJ67X351P9)
  • ALCOHOL (UNII: 3K9958V90M)
  • JOJOBA OIL (UNII: 724GKU717M)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • THYME (UNII: CW657OBU4N)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • UREA (UNII: 8W8T17847W)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Happy Foot Shop, Llc
Labeler Code: 69983
FDA Application Number: part333C What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-09-2015 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: 12-31-2021 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: N 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.

Fungablend 10 Product Label Images

Fungablend 10 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:

Tolnaftate  1.0%

Purpose

Antifungal

Uses

  • Proven clinically effective in the treatment of most athlete's foot (
  • Tinea pedis) and ringworm (
  • Tinea corporis)
  • Helps prevent most athlete's foot with daily useFor effective relief of itching, burning and cracking.

Warnings

  • ​For external use only

Do Not Use

On children under 2 years of age except under the advice and supervision of a doctor

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If:

  • Irritation occursThere is no improvement within 4 weeks

Keep Out Of Reach Of Children.

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

Directions

  • Wash affected area and dry thoroughlyApply a thin layer over affected area twice daily (morning and night) or as directed by a doctorSupervise children in the use of this product​For 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 daily.
  • Use daily for 4 weeks; if condition persists longer, ask a doctorPrevent athlete's foot, apply once or twice daily (morning and/or night)This product is not effective on scalp or nails

Inactive Ingredients:

Ageratina sp. (snakeroot) extract, aloe barbadensis (aloe vera gel) juice, aqua (deionized water), butylene glycol, C13-14 isoparaffin, citrus grandis (grapefruit) fruit extract, citrus medica limonum (lemon) peel oil, ethylhexylglycerin, laureth-7, lavandula officinalis (lavender) oil, melaleuca alternifolia (australia tea tree) leaf oil, origanum vulgare (oregano) leaf oil, phenoxyethanol, polyacrylamide, polysorbate-20, prunus amygdalus dulcis (almond) oil, rosmarinus officinalis (rosemary) leaf extract, SD-alcohol 40B, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) butter, thymus vulgaris (thyme) extract, tocopheryl acetate (vitamin e), urea.

Other Information

Store between 20


​o ​to 25


​o​ C (68​


​o ​​to 77


​o​ F)

* Please review the disclaimer below.