NEWSTEM Rx Ceramide

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 23:05:37

Label at a glance#

ProductNEWSTEM Rx Ceramide

Active ingredientDimethicone, Allantoin

Label structure8 sections

Indications and uses

Uses: NEWSTEM Rx Ceramide Lotion helps sensitive and dry skin to moisturize, rest and protect.

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: Dimethicone 2.0%, Allantoin 0.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Glycerin, Caprylic/Capric Triglyceride, Butylene Glycol, Dipropylene Glycol, Butyrospermum Parkii (Shea) Butter, Pentylene Glycol, Cyclomethicone, Cetearyl Alcohol, BeesWax, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Phenoxyethanol, Human Adipocyte Conditioned Media Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sucrose, Behenyl Alcohol, Glyceryl Citrate/Lactate/Linoleate/Oleate, Serine, Xanthan Gum, Tocopheryl Acetate, Arginine, Mannitol, Olea Europaea (Olive) Fruit Oil, PCA, Alanine, 1,2-Hexanediol, Ammonium Glycyrrhizate, Citric Acid, Disodium EDTA, Threonine, Rhizophora Mangle Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Lilium Candidum Callus Culture Extract, Polysorbate 60, Caprylyl Glycol, Tropolone, Ceramide NP, Sodium Hyaluronate, Caffeine, t-Butyl Alcohol, Zinc Gluconate, Mourera Fluviatilis Extract, Ethylhexylglycerin, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Nicotinoyl sh-Pentapeptide-19, Nicotinoyl Tripeptide-1, sh-Decapeptide-9, Galloyl Pentapeptide-33, Caffeoyl sh-Octapeptide-4, rh-Polypeptide-64, 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 Ceramide Lotion helps sensitive and dry skin to moisturize, rest and protect.

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 Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71759-020-02	2022-01-28	C162847	48780-1	9d75b9cf-dce8-f424-e053-dadaa90a57ce	80267eab-421b-4386-bf95-aa584120a816
71759-020-02	2020-04-10	C162847	48780-1	9d75b9cf-dce8-f424-e053-dadaa90a57ce	80267eab-421b-4386-bf95-aa584120a816
71759-020-02	2020-01-31	C162847	48780-1	9d75b9cf-dce8-f424-e053-dadaa90a57ce	80267eab-421b-4386-bf95-aa584120a816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71759-020-01	NEWSTEM Rx Ceramide	200 mL in 1 BOTTLE, PUMP	LOTION	200		2
71759-020-02	NEWSTEM Rx Ceramide	1 in 1 CARTON	LOTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71759-020	NEWSTEM RX CERAMIDE (DIMETHICONE, ALLANTOIN) LOTION [YJ LAB CO., LTD.]	2	Legacy NDC, 2 package rows	20200410_80267eab-421b-4386-bf95-aa584120a816.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NEWSTEM Rx Ceramide
Dimethicone, Allantoin
Dimethicone
Allantoin
Water
Glycerin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71759-020	71759-020-01, 71759-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Allantoin	344S277G0Z	ACTIB
Water	059QF0KO0R	IACT
Glycerin	PDC6A3C0OX	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
349fe4e4-dcce-439e-af8c-26378701a452			80267eab-421b-4386-bf95-aa584120a816	2020-04-10	Warnings	Exact identifier spl id: 349fe4e4-dcce-439e-af8c-26378701a452 spl set id: 80267eab-421b-4386-bf95-aa584120a816

Reported adverse events (FAERS/openFDA)#

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