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NEWSTEM Rx Intensive

Dosage form: cream
Ingredients: Allantoin 0.075g in 15mL
Labeler: Yj Lab Co., Ltd.
NDC Code: 71759-040

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.

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

NEWSTEM RX INTENSIVE 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71759-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.075 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Butylene Glycol 
Packaging
#Item CodePackage Description
1NDC:71759-040-021 TUBE in 1 CARTON
1NDC:71759-040-0115 mL in 1 TUBE
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/FEIOperations
INNOGENE CO.,LTD688201056manufacture(71759-040)

 
Yj Lab Co., Ltd.

Medically reviewed on Oct 12, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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