OTC Medication Information: Atomu Essence A

ATOMU ESSENCE A- 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 A 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, Ulmus davidiana root extract, Sesamum indicum (Sesame) seed extract, Royal jelly, Quercus acutissima wood vinegar extract, Houttuynia ordata extract, Ecklonia cava extract, Cucumis sativus (Cucumber) fruit extract, Centella asiatica extract, Pinus densiflora leaf extract, Butylene glycol, 1,2-Hexanediol, Allantoin, Lonicera japonica (Honeysuckle) flower extract, Xanthan gum, Rosa damascena flower extract, Oenothera biennis (Evening primrose) flower extract, Nelumbium speciosum flower extract, Lavandula angustifolia (Lavender) flower extract, Inula britannica flower extract, Chrysanthemum indicum flower extract, Carthamus tinctorius (Safflower) flower extract, Calendula officinalis flower extract, Propolis extract, Perilla ocymoides leaf extract, Acorus calamus root extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ATOMU ESSENCE A
allantoin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72544-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (ALLANTOIN) Allantoin 0.25 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
ULMUS DAVIDIANA ROOT
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72544-300-02 1 BOTTLE in 1 CARTON contains a BOTTLE (72544-300-01)
1 NDC:72544-300-01 50 mL in 1 BOTTLE This package is contained within the CARTON (72544-300-02)
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 (72544-300)

Revised: 09/2020 CELIM BIOTECH 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.

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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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