OTC Medication Information: Dr.Different CICA Metal

DR.DIFFERENT CICA METAL- madecassoside and asiaticoside cream
Dareun Cosmetics 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.

ACTIVE INGREDIENTS

Madecassoside 0.26%
Asiaticoside 0.012%

INACTIVE INGREDIENTS

Water, Butylene Glycol, Vegetable Oil, Glycerin, Pentaerythrityl Tetraisostearate, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, 1,2-Hexanediol, Hydrogenated Vegetable Oil, Cetyl Alcohol, Butylene Glycol Dicaprylate/Dicaprate, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Stearic Acid, Sorbitan Sesquioleate, Cetearyl Olivate, Hydrogenated Lecithin, Glyceryl Stearate SE, Sorbitan Olivate, Carbomer, Behenic Acid, Tromethamine, Ethylhexylglycerin, Caprylyl Glycol, Stearyl Alcohol, Behenyl Alcohol, Tocopherol, Xanthan Gum, Myristic Acid, Dextrin, Zinc PCA, Gluconolactone, Centella Asiatica Extract, Copper Tripeptide-1

PURPOSE

Skin treatment

WARNINGS

For external use only.
1. If there is any red spot, swallowing or itching by direct sunlight or if there is any other adverse effect during or after cosmetics use, consult with a doctor.
2. Refrain from using on the injured area.
3. Precaution for storage and handling.
a) Keep out of reach of children.
b) Keep away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Uses

■ Helps repair and soothe the skin.

Directions

After cleansing, take out an adequate amount on a hand, gently apply then dab to help the skin absorb.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DR.DIFFERENT CICA METAL
madecassoside, asiaticoside cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81710-090
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Madecassoside (Madecassoside) Madecassoside 0.26 g in 100 g
Asiaticoside (Asiaticoside) Asiaticoside 0.012 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
Butylene Glycol
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81710-090-02 1 CONTAINER in 1 CARTON contains a CONTAINER (81710-090-01)
1 NDC:81710-090-01 50 g in 1 CONTAINER This package is contained within the CARTON (81710-090-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2021
Labeler — Dareun Cosmetics Co., Ltd. (694894617)
Registrant — Dareun Cosmetics Co., Ltd. (694894617)
Establishment
Name Address ID/FEI Operations
E.CIS COSMETIC.,Co.Ltd 689846270 manufacture (81710-090)

Revised: 08/2021 Dareun Cosmetics Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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