NDC 72839-133 Anti-fungal Buttery Balm Lady Bits

Miconazole Nitrate 2%

NDC Product Code 72839-133

NDC Code: 72839-133

Proprietary Name: Anti-fungal Buttery Balm Lady Bits 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: Miconazole Nitrate 2% 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

  • 72839 - Derma Care Research Labs, Llc
    • 72839-133 - Anti-fungal Buttery Balm

NDC 72839-133-01

Package Description: 25 g in 1 JAR

NDC Product Information

Anti-fungal Buttery Balm Lady Bits with NDC 72839-133 is a a human over the counter drug product labeled by Derma Care Research Labs, Llc. The generic name of Anti-fungal Buttery Balm Lady Bits is miconazole nitrate 2%. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Derma Care Research Labs, Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Anti-fungal Buttery Balm Lady Bits 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 2 g/100g

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.

  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • COCOA (UNII: D9108TZ9KG)
  • VANILLA (UNII: Q74T35078H)
  • WATER (UNII: 059QF0KO0R)
  • MELON (UNII: 5CIT1X6U5V)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CORN OIL (UNII: 8470G57WFM)
  • RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • ANISE (UNII: 21C2F5E8RE)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • 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: Derma Care Research Labs, Llc
Labeler Code: 72839
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: 05-03-2019 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.

Anti-fungal Buttery Balm Lady Bits Product Label Images

Anti-fungal Buttery Balm Lady Bits 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

Miconazole Nitrate 2%

Otc - Purpose

Antifungal

Dosage & Administration

Cures most tinea cruris "jock itch" and tinea corporis "ring worm". Soothes itching, burning, cracking.

Warnings

For external use only.
Avoid contact with eyes.
Do not use on children under 2 years of age unless directed by a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Clean the affected area thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Inactive Ingredient

Aloe barbadensis leaf extract, althaea officinalis root extract, beeswax, butyrospermum park ii (shea) butter, calendula officinalis flower extract, cocos nucifera (coconut) oil, cucumis melo (melon) fruit extract, dipteryx odorata seed extract, glycerin, hydrogenated vegetable oil, olea europaea (olive) fruit oil, pimpinella anisum (anise) fruit extract, ricinus communis (castor) seed oil, theobroma cacao (cocoa) extract, triethyl citrate, vanilla planifolia fruit extract, water

* Please review the disclaimer below.

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