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

Atomu Essence by

Drug Labeling and Warnings

Atomu Essence 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- 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 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, Quercus acutissima wood vinegar 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, Pinus densiflora leaf extract, Butylene glycol, 1,2-Hexanediol, Lonicera japonica (Honeysuckle) flower extract, Xanthan gum, Carthamus tinctorius (Safflower) flower extract, Rosa damascena flower extract, Chrysanthemum indicum flower extract, Calendula officinalis flower extract, Oenothera biennis (Evening primrose) flower extract, Nelumbium speciosum flower extract, Lavandula angustifolia (Lavender) flower extract, Inula britannica flower extract, Propolis extract, Acorus calamus root extract, Perilla ocymoides leaf extract.

PACKAGE LABEL
Atomu Essence 20mL
NDC: 72544-360-02

PACKAGE LABEL
Atomu Essence 50mL
NDC: 72544-360-04

ATOMU ESSENCE 
allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72544-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.50 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Royal jelly (UNII: L497I37F0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72544-360-02	1 in 1 CARTON	09/01/2020	12/30/2020
1	NDC: 72544-360-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 72544-360-04	1 in 1 CARTON	09/01/2020	12/30/2020
2	NDC: 72544-360-03	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	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(72544-360)

Revised: 6/2021

Document Id: 17f3a17c-8af6-45b5-b807-b7a3b6c9ee17

34390-5

Set id: 053dde81-dde6-425b-89d5-7b4b4f94c7e1

Version: 2

Effective Time: 20210617