Label: NEWSTEM RX INTENSIVE- allantoin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 10, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!