Atomu Essence 17: Package Insert and Label Information

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.

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

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ATOMU ESSENCE 17
allantoin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72544-330
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (ALLANTOIN) Allantoin 0.15 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Butylene glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72544-330-02 1 BOTTLE in 1 CARTON contains a BOTTLE (72544-330-01)
1 NDC:72544-330-01 30 mL in 1 BOTTLE This package is contained within the CARTON (72544-330-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/01/2020
Labeler — CELIM BIOTECH CO.,LTD (694860906)
Registrant — CELIM BIOTECH CO.,LTD (694860906)
Establishment
Name Address ID/FEI Operations
Charming Cosmetics. Co. Ltd 689935740 manufacture (72544-330)

Revised: 09/2020 CELIM BIOTECH CO.,LTD

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