NDC 81733-010 Soonreborn Repair Essence

Niacinamide, Adenosine

NDC Product Code 81733-010

NDC 81733-010-02

Package Description: 1 BOTTLE in 1 CARTON > 130 mL in 1 BOTTLE (81733-010-01)

NDC Product Information

Soonreborn Repair Essence with NDC 81733-010 is a a human over the counter drug product labeled by Newborn Korea Co., Ltd.. The generic name of Soonreborn Repair Essence is niacinamide, adenosine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Newborn Korea 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.

Soonreborn Repair 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.

  • NIACINAMIDE 2 g/100mL
  • ADENOSINE .04 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)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Newborn Korea Co., Ltd.
Labeler Code: 81733
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-01-2021 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: 12-31-2022 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.

Soonreborn Repair Essence Product Label Images

Soonreborn Repair 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 Ingredients

Niacinamide 2.0%Adenosine 0.04%

Inactive Ingredients

WATER, HYDROGENATED POLYDECENE, ISONONYL ISONONANOATE, GLYCERIN, OCTYLDODECANOL, 1,2-HEXANEDIOL, CARBOMER, DIPHENYL DIMETHICONE, HYDROXYACETOPHENONE, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL, TROMETHAMINE, AMODIMETHICONE, PROPYLENE CARBONATE, HYDROXYDECYL UBIQUINONE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, FRAGRANCE, DISODIUM EDTA, PHENOXYETHANOL, LACTOBACILLUS/PANAX GINSENG ROOT FERMENT FILTRATE, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, PROPANEDIOL, PORIA COCOS SCLEROTIUM EXTRACT, LEONTOPODIUM ALPINUM CALLUS CULTURE EXTRACT, PANAX GINSENG ROOT EXTRACT, CAPRYLYL GLYCOL, TOCOPHEROL, XANTHAN GUM, SODIUM HYALURONATE

Purpose

Skin brighteningAnti wrinkle

Warnings

For external use only1. If there is any red spot, swallowing or itching by direct sunlight or if there is any other adverse effect during or after cosmetics use, consult with a doctor.2. Refrain from using on the injured area3. Precaution for storage and handlinga) Keep out of reach of childrenb) Keep away from direct sunlight

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps brighten skin tone.■ Helps improve wrinkle problem.

Directions

■ Apply an appropriate amount evenly on the skin.

* Please review the disclaimer below.