NDC 55505-204 Opti-nail 2-in-1

Tolnaftate

NDC Product Code 55505-204

NDC 55505-204-67

Package Description: 1 KIT in 1 CARTON * 5 mL in 1 TUBE, WITH APPLICATOR * 5 mL in 1 TUBE, WITH APPLICATOR

NDC Product Information

Opti-nail 2-in-1 with NDC 55505-204 is a a human over the counter drug product labeled by Kramer Laboratories. The generic name of Opti-nail 2-in-1 is tolnaftate. The product's dosage form is kit and is administered via topical form.

Labeler Name: Kramer Laboratories

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • ETHYL LACTATE (UNII: F3P750VW8I)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • RESACETOPHENONE (UNII: UC3V356VZC)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: 02-01-2021 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: 12-31-2022 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.

Opti-nail 2-in-1 Product Label Images

Opti-nail 2-in-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 - Purpose

Active ingredientPurposeTolnaftate 1%Anti-fungal

Uses

  • Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)helps prevent most athlete’s foot with daily use 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 productavoid contact with eyes.

Otc - Stop Use

  • Stop use and ask a doctor ifirritation occurs there is no improvement within 4 weeks.

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.

Directions:

  • Clean affected area with soap and warm water and dry thoroughly. Apply a thin layer of Maximum Strength Antifungal over affected area twice daily (morning and night) or as directed by a doctor.The brush applicator allows for easy application to skin around the nail.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 to skin around nails. 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 Information

Store at room temperature 15º−30ºC (59º−86ºF).

Inactive Ingredients

Aloe vera (aloe barbadensis) gel, ascorbic acid (vitamin C), dimethicone, DMDM hydantoin, edetate disodium dihydrate, eucalyptol, glycerin, glyceryl stearate SE, lavender oil, mineral oil, olive oil, PEG-100 stearate, phenoxetol, propylene glycol, tea tree oil, titanium dioxide, tocopheryl acetate (vitamin E), xanthan gum, water

* Please review the disclaimer below.