Atomu Cream 17 by CELIM BIOTECH CO.,LTD / Charming Cosmetics. Co. Ltd

Atomu Cream 17 by

Drug Labeling and Warnings

Atomu Cream 17 by is a Otc medication manufactured, distributed, or labeled by CELIM BIOTECH CO.,LTD, Charming Cosmetics. Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ATOMU CREAM 17- allantoin cream 
CELIM BIOTECH CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Allantoin 0.5%

PURPOSE

Skin protectant

Uses

Fine cream-type formulation absorbs into the skin quickly without stickiness. Absorbing gently without skin irritation, the cream with naturally-derived extracts supply oil and moisture helps to retain moisture over time.

WARNINGS

1) If you develop symptoms such as red spots, swelling, or itching due to direct sunlight during or after using cosmetics, please consult a specialist.
2) Do not use the product on wounded areas.
3) Precautions for storage and handling
A - Keep away from the reach of children.
B - Store the product away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep away from the reach of children.

Directions

After cleansing your skin, pat dry and apply an appropriate amount to the required area. Massage gently to help absorption. We recommended using the product 1-2 times daily, especially before bed. Please perform a sensitivity test on the inside of the elbow before using the product. Refrigeration recommended.

QUESTIONS

www.atomu.co.kr
+82-70-4603-1739

INACTIVE INGREDIENTS

Water, Glycerin, Cetearyl alcohol, Caprylic/Capric triglyceride, Butylene glycol, Prunus armeniaca(Apricot) kernel oil, Helianthus annuus (Sunflower) seed oil, Beeswax, Glyceryl stearate SE, Glycol stearate SE, Quercus robur bark extract, Royal jelly, Houttuynia cordata extract, Centella asiatica extract, Sesamum indicum (Sesame) seed extract, Ecklonia cava extract, Ulmus davidiana root extract, Cucumis sativus (Cucumber) fruit extract, 1,2-Hexanediol, Stearic acid, Hydrogenated lecithin, Pinus densiflora leaf extract, Lonicera japonica (Honeysuckle) flower extract, Honey extract, Cetearyl glucoside, Arginine, Lavandula angustifolia (Lavender) oil, Carbomer, Xanthan gum, Lavandula angustifolia (Lavender) extract, Rosmarinus officinalis (Rosemary) extract, Thymus vulgaris (Thyme) extract, Mentha arvensis leaf extract, Borago officinalis extract, Salvia officinalis (Sage) leaf extract, Jasminum officinale (Jasmine) extract, Anthemis nobilis flower extract, Disodium EDTA, Tremella fuciformis (Mushroom) extract, Sodium hyaluronate, Propolis extract, Acorus calamus root extract, Perilla ocymoides leaf extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATOMU CREAM 17 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72544-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72544-350-02	1 in 1 CARTON	09/01/2020	12/30/2020
1	NDC: 72544-350-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2020	12/30/2020

Labeler - CELIM BIOTECH CO.,LTD (694860906)

Registrant - CELIM BIOTECH CO.,LTD (694860906)

Establishment
Name	Address	ID/FEI	Business Operations
Charming Cosmetics. Co. Ltd		689935740	manufacture(72544-350)

Revised: 6/2021

Document Id: 670d8285-4302-4ad0-b89d-e8b095ddfb9d

34390-5

Set id: 6bb2d8ae-e84e-4c36-8f9c-547f8d777089

Version: 2

Effective Time: 20210617