NDC 71237-001 Kaewoon
Glycerin, Allantoin Gel Topical

Product Information

Product Code71237-001
Proprietary Name 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.
Kaewoon
Non-Proprietary Name 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.
Glycerin, Allantoin
Product Type 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.
Human Otc Drug
Dosage FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.
Rncare
Labeler Code71237
Marketing Category 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.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-02-2017
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 71237-001-02

Package Description: 1 BOTTLE in 1 CARTON > 320 mL in 1 BOTTLE (71237-001-01)

Product Details

Kaewoon is a human over the counter drug product labeled by Rncare. The generic name of Kaewoon is glycerin, allantoin. The product's dosage form is gel and is administered via topical form.


What are Kaewoon Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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.

  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
  • PEG-60 CASTOR OIL (UNII: VXP26NM2XX)
  • RICE BRAN (UNII: R60QEP13IC)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • TURMERIC (UNII: 856YO1Z64F)
  • MUNG BEAN (UNII: 1LIB31N73G)
  • ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
  • CRATAEGUS LAEVIGATA FLOWER (UNII: 85EAT04F4H)
  • RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
  • BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • AMINOCAPROIC ACID (UNII: U6F3787206)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HEXANEDIOL (UNII: ZIA319275I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


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Kaewoon Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Glycerin 3%

Allantoin 0.2%


Otc - Purpose



Skin Protectant


Indications & Usage



Body Cleansing


Dosage & Administration



Take an appropriate amount and massage onto scalp/body for about 60 seconds and rinse with water


Warnings



In case of eye contact, immediately rinse with water

Stop use if unusual redness, swelling, soreness or irritation occur


Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Inactive Ingredient



Cocamide DEA, Oleic Acid, Lauramidopropyl Betaine, PEG-60 Castor Oil, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Shea Butteramidopropyl Betaine, Polysorbate 80, Water, Propylene Glycol, Sodium Cocoamphoacetate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Lecithin, Curcuma Longa (Turmeric) Root Extract, Phaseolus Radiatus Seed Extract, Artemisia Vulgaris Extract, Arctium Lappa Root Extract, Hippophae Rhamnoides Extract, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Eucalyptus Globulus Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Panax Ginseng Root Extract, Propolis Extract, 6-Aminocaproic Acid, Polyquaternium, Disodium EDTA, Black Strap Powder, Hexanediol, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Hydroxyethylcellulose, Menthol, Citric Acid, Frageance


Package Label.Principal Display Panel




* Please review the disclaimer below.