NDC 55505-177 Fungi Nail Toe And Foot

Tolnaftate

NDC Product Code 55505-177

NDC Code: 55505-177

Proprietary Name: Fungi Nail Toe And Foot 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 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.


Code Structure
  • 55505 - Kramer Laboratories
    • 55505-177 - Fungi Nail Toe And Foot

NDC 55505-177-26

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

NDC Product Information

Fungi Nail Toe And Foot with NDC 55505-177 is a a human over the counter drug product labeled by Kramer Laboratories. The generic name of Fungi Nail Toe And Foot is tolnaftate. The product's dosage form is solution and is administered via topical form.

Labeler Name: Kramer Laboratories

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.


Fungi Nail Toe And Foot 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)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIMETHICONE 350 (UNII: 2Y53S6ATLU)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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: Kramer Laboratories
Labeler Code: 55505
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: 03-25-2019 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.

Fungi Nail Toe And Foot Product Label Images

Fungi Nail Toe And Foot 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 - Purpose

Active IngredientPurposeTolnaftate 1%Anti-fungal

Indications & Usage

Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) ■ For effective relief of itching, burning and cracking.

Warnings

For external use only.

Otc - Do Not Use

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

Otc - When Using

When using this product ■ avoid contact with eyes.

Otc - Stop Use

Stop use and ask a doctor if ■ irritation occurs ■ there 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 areas 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 area. ■ 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 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.

Storage And Handling

Other informationStore at controlled room temperature 15°-30° C (59°-86° F) Protect from freezing. If freezing occurs warm to room temperature.

Inactive Ingredient

Inactive ingredientsAloe 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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