NDC 68599-1471 Miconazole Nitrate

Antifungal

NDC Product Code 68599-1471

NDC Product Information

Miconazole Nitrate with NDC 68599-1471 is a a human over the counter drug product labeled by Mckesson. The generic name of Miconazole Nitrate is antifungal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Mckesson

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Miconazole Nitrate 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.

  • MICONAZOLE NITRATE 100 mg/2mg

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.

  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

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: Mckesson
Labeler Code: 68599
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: 07-25-2019 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.

Miconazole Nitrate Product Label Images

Miconazole Nitrate 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredientMiconazole Nitrate 2%

Otc - Purpose

PurposeAntifungal

Indications & Usage

UsesTreats most jock itch, ringworm and athlete’s foot

Warnings

  • WarningsDo not use on children under 2 years of age for diaper rash.For external use only.Avoid contact with eyes.

Otc - Stop Use

Consult a DoctorIf irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm,or within 2 weeks for jock itch.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsClean the affected area and dry thoroughly.Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.Supervise children in the use of this product.Athlete’s footPay special attention to the spaces between toeswear well-fitting, ventilated shoes and change shoes and socks at least once dailyAthlete’s foot and ringwormuse daily for 4 weeksJock Itchuse daily for 2 weeks.If condition persists longer, consult a doctor.

Other Safety Information

  • Other InformationThis product is not effective on scalp or nails.Store at 59-86ºF (15-30ºC).

Inactive Ingredient

Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,

DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,
Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).

* Please review the disclaimer below.

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