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

Atomu Essence 17 by

Drug Labeling and Warnings

Atomu Essence 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 ESSENCE 17- allantoin liquid 
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

Atomu Essence 17 moisturizes and softens dry skin, and provides rich nutrition for a silky and glossy complexion. Ingredients from nature help to retain healthy skin.

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 three times a day, 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, Butylene glycol, Dipropylene glycol, Prunus armeniaca (Apricot) kernel oil, Camellia japonica seed oil, Niacinamide, Quercus robur bark extract, Cetearyl alcohol, Houttuynia cordata extract, Centella asiatica extract, Sesamum indicum (Sesame) seed extractz', Pinus densiflora leaf extract, 1,2-Hexanediol, Ecklonia cava extract, Ulmus davidiana root extract, Cucumis sativus (Cucumber) fruit extract, Lonicera japonica (Honeysuckle) flower extract, Honey extract, Cetearyl glucoside, Lavandula angustifolia (Lavender) oil, Royal jelly, Xanthan gum, Lavandula angustifolia extract, Rosmarinus officinalis extract, Thymus vulgaris extract, Mentha arvensis leaf extract, Borago officinalis extract, Salvia officinalis (Sage) leaf extract, Jasminum officinale (Jasmine) extract, Anthemis nobilis flower extract, Disodium EDTA, Adenosine, Tremella fuciformis extract, Sodium hyaluronate, Hydrolyzed collagen, Ascorbic acid, Propolis extract, Acorus calamus root extract, Perilla ocymoides leaf extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATOMU ESSENCE 17 
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72544-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Butylene glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72544-320-02	1 in 1 CARTON	09/01/2020	09/14/2020
1	NDC: 72544-320-01	50 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	09/14/2020

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(72544-320)

Revised: 9/2020

Document Id: 6d7eed36-7894-41ad-8a3d-f7a9565f26b9

34390-5

Set id: 50ce6388-30ec-4499-85d5-1cc2da7cf356

Version: 2

Effective Time: 20200914