OTC Medication Information: ATOMU 17 Plus

ATOMU 17 PLUS- allantoin lotion
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

Active ingredients: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Prunus armeniaca (Apricot) kernel oil, Caprylic/Capric triglyceride, Isopropyl myristate, Dipropylene glycol, Cetearyl alcohol, Pinus densiflora leaf extract, Quercus acutissima wood vinegar extract, Glyceryl stearate, Sorbitan stearate, Stearic acid, 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, Butylene glycol, 1,2-Hexanediol, Lonicera japonica (Honeysuckle) flower extract, Sorbitan sesquioleate, Arginine, Lavandula angustifolia (Lavender) oil, Carbomer, 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, Disodium EDTA, Tremella fuciformis (Mushroom) extract, Sodium hyaluronate, Propolis extract, Acorus calamus root extract, Perilla ocymoides leaf extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

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

Uses

Uses:

It is a fine lotion type formulation which incorporates 17% of Atomu Essence. It absorbs into skin quickly and can be used without feeling sticky. It absorbs gently without any skin irritation. Lotion with natural extracts helps to keep skin moisturized and hydrated for a long period of time.

Directions

Directions:

After washing your face, dry your skin, apply an appropriate amount of the product to the required area and massage lightly to help your skin absorb the product. We recommend you to use the product three times a day, especially before bedtime. Please perform a sensitivity test inside the elbow before using the product. You can experience more dramatic results by using Atomu Essence together.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ATOMU 17 PLUS
allantoin lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72544-050
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (ALLANTOIN) Allantoin 0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72544-050-02 1 CONTAINER in 1 CARTON contains a CONTAINER (72544-050-01)
1 NDC:72544-050-01 100 mL in 1 CONTAINER This package is contained within the CARTON (72544-050-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/01/2018
Labeler — CELIM BIOTECH CO.,LTD (694860906)
Registrant — CELIM BIOTECH CO.,LTD (694860906)
Establishment
Name Address ID/FEI Operations
Charming Cosmetics. Co. Ltd 689935740 manufacture (72544-050)

Revised: 07/2020 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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