NEWSTEM RX INTENSIVE- 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: Allantoin 0.5%

INACTIVE INGREDIENT

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

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 Intensive Cream helps sensitive and damaged skin to rest and strong protection.

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 INTENSIVE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71759-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.075 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71759-040-021 in 1 CARTON09/01/2017
1NDC:71759-040-0115 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(71759-040)

Revised: 4/2020
Document Id: 550fb7c9-7f5a-45db-ae83-07a73eef4144
Set id: 1551545a-3441-449b-8006-8fc578b184a3
Version: 2
Effective Time: 20200410
 
Yj Lab Co., Ltd.