NDC 81733-020 Soonreborn Repair

Niacinamide, Adenosine

NDC Product Code 81733-020

NDC 81733-020-02

Package Description: 1 CONTAINER in 1 CARTON > 50 mL in 1 CONTAINER (81733-020-01)

NDC Product Information

Soonreborn Repair with NDC 81733-020 is a a human over the counter drug product labeled by Newborn Korea Co., Ltd.. The generic name of Soonreborn Repair is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Newborn Korea Co., Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 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)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • 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 Product Label Images

Soonreborn Repair 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, DIPROPYLENE GLYCOL, HYDROGENATED POLYDECENE, GLYCERIN, CYCLOHEXASILOXANE, GLYCERYL STEARATE, CETEARYL ALCOHOL, BUTYLENE GLYCOL, PENTAERYTHRITYL TETRAETHYLHEXANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICAPRYLYL ETHER, POLYGLYCERYL-10 LAURATE, BEESWAX, 1,2-HEXANEDIOL, SODIUM STEAROYL GLUTAMATE, JOJOBA ESTERS, PHENOXYETHANOL, LAMINARIA JAPONICA EXTRACT, ECLIPTA PROSTRATA LEAF EXTRACT, BISABOLOL, TRANEXAMIC ACID, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, HYDROXYACETOPHENONE, ALCOHOL, ETHYLHEXYLGLYCERIN, LACTOBACILLUS/PANAX GINSENG ROOT FERMENT FILTRATE, FRAGRANCE, FRUCTOOLIGOSACCHARIDES, DISODIUM EDTA, HYDROGENATED LECITHIN, BETA-GLUCAN, SODIUM LAURATE, XANTHAN GUM, POLYGLYCERIN-3, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, PENTYLENE GLYCOL, PHELLODENDRON AMURENSE BARK EXTRACT, HYDROLYZED HYALURONIC ACID, LAURIC ACID, DEXTRIN, THEOBROMA CACAO (COCOA) SEED EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, SOPHORA FLAVESCENS ROOT EXTRACT, RHEUM PALMATUM ROOT/STALK EXTRACT, GANODERMA LUCIDUM (MUSHROOM) STEM EXTRACT, PROPANEDIOL, PORIA COCOS SCLEROTIUM EXTRACT, TOCOPHEROL, LEONTOPODIUM ALPINUM CALLUS CULTURE EXTRACT, PANAX GINSENG ROOT EXTRACT, CAPRYLYL GLYCOL, HYDROXYDECYL UBIQUINONE, 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.