NDC 81810-305 Queen79 Noble Goldcream

Glycerin

NDC Product Code 81810-305

NDC CODE: 81810-305

Proprietary Name: Queen79 Noble Goldcream 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: Glycerin 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

  • 81810 - Enna Cosmetic, Inc.

NDC 81810-305-01

Package Description: 50 mL in 1 JAR

NDC Product Information

Queen79 Noble Goldcream with NDC 81810-305 is a a human over the counter drug product labeled by Enna Cosmetic, Inc.. The generic name of Queen79 Noble Goldcream is glycerin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Enna Cosmetic, Inc.

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.

Queen79 Noble Goldcream 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.

  • GLYCERIN 5 mg/100mL

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.

  • PRUNUS MUME FLOWER (UNII: 2N8872050J)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALLANTOIN (UNII: 344S277G0Z)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • JUJUBE FRUIT (UNII: G55HNL2C70)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • STAR ANISE FRUIT (UNII: CK15HA8438)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • ARGININE (UNII: 94ZLA3W45F)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • LAVANDIN OIL (UNII: 9RES347CKG)
  • GINKGO (UNII: 19FUJ2C58T)
  • SILK SERICIN (UNII: 0N1VMU8G9W)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ADENOSINE (UNII: K72T3FS567)
  • ICODEXTRIN (UNII: 2NX48Z0A9G)
  • COCOA (UNII: D9108TZ9KG)
  • POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • PYRUS COMMUNIS FLOWER (UNII: P6Y3X4TOIW)
  • GOLD (UNII: 79Y1949PYO)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • BABASSU OIL (UNII: 8QSB4M5477)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • NIACINAMIDE (UNII: 25X51I8RD4)

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: Enna Cosmetic, Inc.
Labeler Code: 81810
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-18-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Queen79 Noble Goldcream Product Label Images

Queen79 Noble Goldcream 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

Active Ingredients

Glycerin(5%)

Purpose

Skin Protectant

Uses

Soft cream type molds provides moistue and nourishment to the thinning skin barrier due to the external environment to help regenerate the skin and provide a deep moisturizing sensation. It smooths the skin's texture and helps create glowing skin.

Warning

For external use only

Stop Use And Ask Doctor If

There are abnormal symptoms or side effects, such as red spot, swelling, or itching etc.

Do Not Use

In the area with wound.

Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

In the morning and evening skin care cream stages, take the appropriate amount and gently spread it over the irritated, sensitive skin, then gently cover the skin with your palm to absorb it. When the skin texture feels bumpy, apply it to the face and massage it gently.

Other Information

Keep it away from direct sunlight.

Inactive Ingredients

Water, Propanediol, Butylene Glycol Dicaprylate/Dicaprate, Polyglyceryl-3 Methylglucose Distearate, Niacinamide, Caprylic/Capric Triglyceride, Phenyl Trimethicone, Hydrogenated Polyisobutene, Cetearyl Alcohol, Cetearyl Olivate, Methyl Gluceth-20, Orbignya Oleifera Seed Oil, Phytosteryl Macadamiate, Arginine, Carbomer, Glyceryl Glucoside, Allantoin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Gold(100ppm), Adenosine, Gardenia Florida Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Zizyphus Jujuba Fruit Extract, Prunus Mume Flower Extract, Dextrin, Butylene Glycol, Pyrus Communis (Pear) Flower Extract, Sericin, Sodium Hyaluronate, Sodium hyaluronate Crosspolymer, Sorbitan Olivate, Ethylhexylglycerin, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Phellinus Linteus Extract, Cnidium Officinale Root Extract, Pentylene Glycol, Lentinus Edodes Extract, Hydrolyzed Sodium Hyaluronate, Hydrolyzed Collagen, Hydrolyzed Hyaluronic Acid, Hyaluronic Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Pelargonium Graveolens Flower Oil, Lavandula Hybrida Oil, Illicium Verum (Anise) Fruit Extract, Scutellaria Baicalensis Root Extract, 1,2-Hexanediol

* Please review the disclaimer below.