NEWSTEM RX CERAMIDE- dimethicone, allantoin cream 
Yj Lab Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: Dimethicone 1.0%, Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Caprylic/Capric Triglyceride, Butylene Glycol, Dipropylene Glycol, Pentylene Glycol, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Dicaprylyl Carbonate, Stearic Acid, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Sesquioleate, Sucrose, Phenoxyethanol, Sodium Polyacrylate, Human Adipocyte Conditioned Media Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Serine, Behenyl Alcohol, Ceramide NP, Arginine, Glyceryl Citrate/Lactate/Linoleate/Oleate, PCA, Tocopheryl Acetate, Mannitol, Alanine, Olea Europaea (Olive) Fruit Oil, Sodium Hyaluronate, Threonine, Citric Acid, Rhizophora Mangle Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Lilium Candidum Callus Culture Extract, Pisum Sativum (Pea) Extract, Ammonium Glycyrrhizate, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Tropolone, Ethylhexylglycerin, Mourera Fluviatilis Extract, Caffeine, t-Butyl Alcohol, Zinc Gluconate, 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 Cream 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

Image of carton

NEWSTEM RX CERAMIDE 
dimethicone, allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71759-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.0 g  in 100 mL
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71759-010-021 in 1 CARTON09/01/2017
1NDC:71759-010-01100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2017
Labeler - Yj Lab Co., Ltd. (693900819)
Registrant - Yj Lab Co., Ltd. (693900819)
Establishment
NameAddressID/FEIBusiness Operations
Innogene Co.,Ltd694396092manufacture(71759-010)

Revised: 4/2020
Document Id: 31d474d7-aab3-465b-b264-298f2d25de64
Set id: dff786fd-0e37-4a87-8a1b-0e585dbb4091
Version: 2
Effective Time: 20200410
 
Yj Lab Co., Ltd.