NEWSTEM RX FRACTIONAL- 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 3.0%, Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Caprylic/Capric Triglyceride, Butylene Glycol, Dipropylene Glycol, Pentylene Glycol, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Sesquioleate, Human Adipocyte Conditioned Media Extract, Sucrose, Phenoxyethanol, Sodium Polyacrylate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Serine, Glyceryl Citrate/Lactate/Linoleate/Oleate, Behenyl Alcohol, Arginine, PCA, Tocopheryl Acetate, Olea Europaea (Olive) Fruit Oil, Mannitol, Alanine, Sodium Hyaluronate, 1,2-Hexanediol, Threonine, Citric Acid, Disodium EDTA, Pisum Sativum (Pea) Extract, Ammonium Glycyrrhizate, Caprylyl Glycol, Tropolone, Rhizophora Mangle Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Lilium Candidum Callus Culture Extract, Ceramide NP, Copper Tripeptide-1, Ethylhexylglycerin, Caffeine, Mourera Fluviatilis Extract, t-Butyl Alcohol, Zinc Gluconate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, sh-Decapeptide-9, Galloyl Pentapeptide-33, Caffeoyl sh-Octapeptide-4, Nicotinoyl sh-Pentapeptide-19, Nicotinoyl Tripeptide-1, sh-Oligopeptide-1, sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-22, rh-Oligopeptide-33, rh-Polypeptide-64

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 Fractional Cream helps sensitive and damaged skin to protect, moisturize and rest.

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 FRACTIONAL 
dimethicone, allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71759-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone3.0 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:71759-030-021 in 1 CARTON09/01/2017
1NDC:71759-030-01100 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(71759-030)

Revised: 4/2020
Document Id: e9a72c17-a570-4dbe-a46f-bf14722d15cf
Set id: c9d99147-185e-4733-8fbc-f10781c729c5
Version: 2
Effective Time: 20200410
 
Yj Lab Co., Ltd.