NEWSTEM RX CERAMIDE- dimethicone, allantoin lotion

NEWSTEM Rx Ceramide by

Drug Labeling and Warnings

NEWSTEM Rx Ceramide by is a Otc medication manufactured, distributed, or labeled by Yj Lab Co., Ltd., Innogene Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Dimethicone 2.0%, Allantoin 0.5%

INACTIVE INGREDIENT

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

Purpose: Skin Protectant

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Uses

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

Directions

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

INGREDIENTS AND APPEARANCE

NEWSTEM RX CERAMIDE 
dimethicone, allantoin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71759-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	4.0 g  in 200 mL
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	1.0 g  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71759-020-02	1 in 1 CARTON	09/01/2017
1	NDC: 71759-020-01	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2017

Labeler - Yj Lab Co., Ltd. (693900819)

Registrant - Yj Lab Co., Ltd. (693900819)

Establishment
Name	Address	ID/FEI	Business Operations
Innogene Co.,Ltd		694396092	manufacture(71759-020)