NDC 80395-201 Red Propolis 30 Vita Ampule

Glycerin, Panthenol, Niacinamide

NDC Product Code 80395-201

NDC CODE: 80395-201

Proprietary Name: Red Propolis 30 Vita Ampule 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, Panthenol, Niacinamide 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.
  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.

NDC Code Structure

  • 80395 - Leejiham

NDC 80395-201-01

Package Description: 35 mL in 1 BOTTLE, DROPPER

NDC Product Information

Red Propolis 30 Vita Ampule with NDC 80395-201 is a a human over the counter drug product labeled by Leejiham. The generic name of Red Propolis 30 Vita Ampule is glycerin, panthenol, niacinamide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Leejiham

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Red Propolis 30 Vita Ampule 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 g/100mL
  • NIACINAMIDE 2 g/100mL
  • PANTHENOL 3 g/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.

  • HYALURONIC ACID (UNII: S270N0TRQY)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
  • ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ADENOSINE (UNII: K72T3FS567)
  • HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

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.
  • 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: Leejiham
Labeler Code: 80395
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-01-2020 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: 12-31-2021 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.

Red Propolis 30 Vita Ampule Product Label Images

Red Propolis 30 Vita Ampule 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 Ingredient

Glycerin 5%Panthenol 3%Niacinamide 2%

Purpose

Skin protectantWhitening

Uses

For healthy-looking skin by caring antioxidant with red propolis extract and providing nourishment

Warnings

For external use only

Stop Use And Ask A Physician

If skin irritation and redness occurs more than 72 hours.

Do Not Use

On damaged or broken skin

Keep Out Of Reach Of Children

If swallowed, get medical help right away.

Directions

After using a toner, apply 2~3 drops and gently pat to absorb

Inactive Ingredients

Water, Propolis Extract, Methylpropanediol, Dipropylene Glycol, Glycerin, Panthenol, Niacinamide, Hydroxyacetophenone, Carbomer, Tromethamine, Caprylyl Glycol, Eclipta Prostrata Extract, Coccinia Indica Fruit Extract, 1,2-Hexanediol, Hyaluronic Acid Propanediol, Adenosine, Disodium EDTA, Benzyl Glycol, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Ethylhexylglycerin, Dipotassium Glycyrrhizate, Sodium Hyaluronate Crosspolymer, Magnesium Ascorbyl Phosphate, Ascorbic Acid, Hydrolyzed Hyaluronic Acid, Hydroxypropyltrimonium Hyaluronate, Sodium Acetylated Hyaluronate

Other Information

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