NEWSTEM Rx Intensive

Manufacturer: Yj Lab Co., Ltd. | Innogene Co.,Ltd
Effective date: 2020-04-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:05:36

Label at a glance#

ProductNEWSTEM Rx Intensive

Active ingredientAllantoin

Label structure8 sections

Indications and uses

Uses: NEWSTEM Rx Intensive Cream helps sensitive and damaged skin to rest and strong protection.

Dosage and administration

Directions: Apply proper amount to sensitive and dry skin after shower. Massage it evenly. Once or twice daily use recommended.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Allantoin 0.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Pentylene Glycol, Dicaprylyl Carbonate, Sucrose Polystearate, Cetyl Ethylhexanoate, Cetearyl Alcohol, BeesWax, Panthenol, Glyceryl Stearate, PEG-100 Stearate, Hydrogenated Polyisobutene, Dimethicone, Sodium Polyacrylate, Human Adipocyte Conditioned Media Extract, Mannitol, Phenoxyethanol, Behenyl Alcohol, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Ammonium Glycyrrhizate, Tocopheryl Acetate, Olea Europaea (Olive) Fruit Oil, 1,2-Hexanediol, Copper Tripeptide-1, Pisum Sativum (Pea) Extract, Polysorbate 60, Disodium EDTA, Caprylyl Glycol, Tropolone, Caffeine, Sodium Hyaluronate, Zinc Gluconate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ethylhexylglycerin, sh-Decapeptide-9, Galloyl Pentapeptide-33, Caffeoyl sh-Octapeptide-4, sh-Oligopeptide-1, sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-22, rh-Oligopeptide-33

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: For external use only 1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist. 2. Do not apply on skin conditions such as wounds. 3. Storage and Handling. a. Keep out of the reach of children. b. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses: NEWSTEM Rx Intensive Cream helps sensitive and damaged skin to rest and strong protection.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply proper amount to sensitive and dry skin after shower. Massage it evenly. Once or twice daily use recommended.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
241509	allantoin 0.5 % Topical Cream	PSN	2
241509	allantoin 5 MG/ML Topical Cream	SCD	2
241509	allantoin 0.5 % Topical Cream	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71759-040-02	2022-01-28	C162847	48780-1	9d75b9cf-dceb-f424-e053-dadaa90a57ce	1551545a-3441-449b-8006-8fc578b184a3
71759-040-02	2020-04-10	C162847	48780-1	9d75b9cf-dceb-f424-e053-dadaa90a57ce	1551545a-3441-449b-8006-8fc578b184a3
71759-040-02	2020-01-31	C162847	48780-1	9d75b9cf-dceb-f424-e053-dadaa90a57ce	1551545a-3441-449b-8006-8fc578b184a3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71759-040-01	NEWSTEM Rx Intensive	15 mL in 1 TUBE	CREAM	15		2
71759-040-02	NEWSTEM Rx Intensive	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71759-040	NEWSTEM RX INTENSIVE (ALLANTOIN) CREAM [YJ LAB CO., LTD.]	2	Legacy NDC, 2 package rows	20200410_1551545a-3441-449b-8006-8fc578b184a3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NEWSTEM Rx Intensive
Allantoin
Water
Butylene Glycol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71759-040	71759-040-01, 71759-040-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Allantoin	344S277G0Z	ACTIB
Water	059QF0KO0R	IACT
Butylene Glycol	3XUS85K0RA	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
550fb7c9-7f5a-45db-ae83-07a73eef4144			1551545a-3441-449b-8006-8fc578b184a3	2020-04-10	Warnings	Exact identifier spl id: 550fb7c9-7f5a-45db-ae83-07a73eef4144 spl set id: 1551545a-3441-449b-8006-8fc578b184a3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.