NDC 72544-360 Atomu Essence

Allantoin

NDC Product Code 72544-360

NDC 72544-360-02

Package Description: 1 BOTTLE in 1 CARTON > 20 mL in 1 BOTTLE (72544-360-01)

NDC 72544-360-04

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE (72544-360-03)

NDC Product Information

Atomu Essence with NDC 72544-360 is a a human over the counter drug product labeled by Celim Biotech Co.,ltd. The generic name of Atomu Essence is allantoin. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Celim Biotech Co.,ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Atomu Essence Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALLANTOIN .5 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ROYAL JELLY (UNII: L497I37F0C)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Celim Biotech Co.,ltd
Labeler Code: 72544
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Atomu Essence Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 handlingA - 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.

* Please review the disclaimer below.