NDC 0295-9017 Maximum Strength Anti Fungal Tolnaftate 1%

Tolnaftate 1%

NDC Product Code 0295-9017

NDC Code: 0295-9017

Proprietary Name: Maximum Strength Anti Fungal Tolnaftate 1% 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: Tolnaftate 1% 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

  • 0295 - Denison Pharmaceuticals, Llc
    • 0295-9017 - Maximum Strength Anti Fungal Tolnaftate 1%

NDC 0295-9017-07

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 30 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Maximum Strength Anti Fungal Tolnaftate 1% with NDC 0295-9017 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Maximum Strength Anti Fungal Tolnaftate 1% is tolnaftate 1%. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, 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.

Maximum Strength Anti Fungal Tolnaftate 1% 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 1 g/100mL

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)
  • DIMETHICONE 350 (UNII: 2Y53S6ATLU)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Denison Pharmaceuticals, Llc
Labeler Code: 0295
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: 07-11-2019 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: 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.

Maximum Strength Anti Fungal Tolnaftate 1% Product Label Images

Maximum Strength Anti Fungal Tolnaftate 1% 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

Otc - Active Ingredient

Active ingredientTolnaftate 1%

Otc - Purpose

PurposeAnti-fungal

Indications & Usage

  • UsesProven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)For effective relief of itching, burning and cracking.

Warnings

WarningsFor external use only.

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor.
When using this product avoid contact with eyes.

Otc - Stop Use

  • Stop use and ask a doctor if irritation occursthere is no improvement within 4 weeks.

Otc - Keep Out Of Reach Of Children

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

Dosage & Administration

  • Directions:Clean affected area with soap and warm water and dry thoroughly.Apply a thin layer of Fungi-Nail® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor.The brush applicator allows for easy application on skin around the nail and cuticle areas.Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.For athlete's foot pay special attention to spaces between the toes.For athlete's foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around cuticle areas. If condition persists longer, consult a doctor.This product is not effective on the scalp or nails.Supervise children in the use of this product.

Other Safety Information

Other information: Store at room temperature 15°-30°C (59°-86°). Protect from freezing. If freezing occurs warm to room temperature.

Inactive Ingredient

Inactive ingredientAloe Vera Leaf, Benzoic Acid, Caprylyl Glycol, Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked), Citric Acid, Dimethicone 350, Ethylhexyl Glycerin, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Olive Oil, Phenoxyethanol, Poloxamer 188, Purified Water USP, Sodium Hydroxide, Tea Tree Oil, Triethyl Citrate

* Please review the disclaimer below.

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