NDC 0295-9024 Maximum Strength Anti Fungal Liquid

Tolnaftate 1%

NDC Product Code 0295-9024

NDC 0295-9024-16

Package Description: 1 APPLICATOR in 1 BOX > 3 mL in 1 APPLICATOR

NDC Product Information

Maximum Strength Anti Fungal Liquid with NDC 0295-9024 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Maximum Strength Anti Fungal Liquid 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 Liquid 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.

  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHICONE 350 (UNII: 2Y53S6ATLU)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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.
  • 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: 11-20-2019 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’.

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Information for Patients

Tolnaftate

Tolnaftate is pronounced as (tole naf' tate)

Why is tolnaftate medication prescribed?
Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm.This medication is sometimes prescribed for other uses;...
[Read More]

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Maximum Strength Anti Fungal Liquid Product Label Images

Maximum Strength Anti Fungal Liquid 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)Helps prevent most athlete's foot with daily useFor 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.To prevent athlete's foot apply under nail and cuticle area. 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, Dimethicone 350, DMDM Hydantoin, Ededtate Disodium Dihydrate, Eucalyptol, Glycerin, Glyceryl Monostearate, Lavender Oil, Mineral Oil, Olive Oil, PEG 100 Stearate, Phenoxyethanol, Propylene Glycol, Water, Sodium Hydroxide, Tea Tree Oil, Titanium Dioxide, Xanthan Gum

* Please review the disclaimer below.