NDC 70514-0013 Karatica Im Cica Essence Pack

Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid

NDC Product Code 70514-0013

NDC Code: 70514-0013

Proprietary Name: Karatica Im Cica Essence Pack 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: Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid 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

  • 70514 - Karatica Co., Ltd

NDC 70514-0013-1

Package Description: 100 mL in 1 TUBE

NDC Product Information

Karatica Im Cica Essence Pack with NDC 70514-0013 is a a human over the counter drug product labeled by Karatica Co., Ltd. The generic name of Karatica Im Cica Essence Pack is madecassoside, asiaticoside, madecassic acid, asiatic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Karatica Co., Ltd

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.

Karatica Im Cica Essence Pack 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.

  • ASIATICOSIDE .01 g/100mL
  • MADECASSOSIDE .01 g/100mL
  • MADECASSIC ACID .01 g/100mL
  • ASIATIC ACID .01 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.

  • WATER (UNII: 059QF0KO0R)

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: Karatica Co., Ltd
Labeler Code: 70514
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: 08-17-2019 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.

Karatica Im Cica Essence Pack Product Label Images

Karatica Im Cica Essence Pack 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

Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid

Inactive Ingredient

Water

MethylPerfluoroisobutylEther

Glycerin

ButyleneGlycol

Caprylic/CapricTriglyceride

ButyleneGlycolDicaprylate/Dicaprate

Cyclopentasiloxane

CetearylAlcohol

Coco-glucoside

Cyclohexasiloxane

GlycerylStearate

PEG-100 Stearate

PalmiticAcid

AmmoniumAcryloyldimethyltaurate/VP Copolymer

StearicAcid

SodiumLauroylGlutamate

HydrogenatedLecithin

CoptisJaponicaExtract

Propanediol

HydrolyzedPeaProtein

Prunus Amygdalus Dulcis (Sweet Almond) Shell Powder

Carbomer 940

Arginine

Betaine

ButyrospermumParkii (Shea) Butter

Ceramide NP

Melaleuca Alternifolia (Tea Tree) Leaf Water

Chlorophyllin-Copper Complex

CitricAcid

BetaineSalicylate

Gluconolactone

XanthanGum

HydrogenatedPolydecene

LauricAcid

MyristicAcid

SucroseStearate

Phytosterol

HydrogenatedPhosphatidylcholine

Lecithin

Olea Europaea (Olive) Fruit Oil

Squalane

SodiumPolyacrylate

Allantoin

1,2-Hexanediol

PentyleneGlycol

Chlorphenesin

Disodium EDTA

Fragrance

t-ButylAlcohol

Trideceth-6

Otc - Purpose

Removal of sebum and waste

Otc - Keep Out Of Reach Of Children

Keep out or reach of the children

Indications & Usage

1.Turn on the brush and press the tube.

2.Gently apply on face avoiding eyes and lips and wait for bubbles.

3.When bubble forms, softly massage face with brush. Then wash off with warm water.

4.Make sure to turn off the brush and cleanse the brush after each use.

Warnings

1) Discontinue use or consult dermatologist if irritation, itching or swelling appears after applying the product.2) Avoid applying product on the wounded, inflamed skin parts.3) Cautions for the storage and handing a)Keep out of children. b)Avoid direct sun light c)Avoid applying around eyes

Dosage & Administration

For external use only

* Please review the disclaimer below.