KARATICA IM CICA ESSENCE PACK: Package Insert and Label Information

KARATICA IM CICA ESSENCE PACK- asiaticoside, madecassoside, madecassic acid and asiatic acid liquid
Karatica Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid

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

Removal of sebum and waste

keep out or reach of the children

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.

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

for external use only

label
(click image for full-size original)

KARATICA IM CICA ESSENCE PACK madecassoside, asiaticoside, madecassic acid, asiatic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70514-0013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASIATICOSIDE (ASIATICOSIDE) ASIATICOSIDE 0.01 g in 100 mL
MADECASSOSIDE (MADECASSOSIDE) MADECASSOSIDE 0.01 g in 100 mL
MADECASSIC ACID (MADECASSIC ACID) MADECASSIC ACID 0.01 g in 100 mL
ASIATIC ACID (ASIATIC ACID) ASIATIC ACID 0.01 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70514-0013-1 100 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/17/2019
Labeler — Karatica Co., Ltd (689605545)
Registrant — Karatica Co., Ltd (689605545)
Establishment
Name Address ID/FEI Operations
Karatica Co., Ltd 689605545 manufacture (70514-0013), label (70514-0013), pack (70514-0013)

Revised: 08/2019 Karatica Co., Ltd

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