Label: NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML- colloidal oatmeal cream

  • NDC Code(s): 71447-030-00, 71447-030-01
  • Packager: LABORATOIRES DRUIDE INC
  • 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 October 14, 2021

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

  • DRUG FACTS

  • Active Ingredients

    Colloidal Oatmeal 1.3%

  • Purpose

    Skin Protectant

  • Uses

    ▪ Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

  • Warnings

    For external use only

  • Do not use

    Consult a healthcare practitioner if symptoms worsen or last for more than 7 days.

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    rash occurs.

  • Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    ▪ Apply to affected area as needed.

  • Other Information

    Protect the product in this container from excessive heat and direct sun. Store the product at room temperature 20 to 25°C (68 to 77°F).

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice*, C10-18 Triglycerides, Oenothera Biennis (Evening Primrose) Oil*, Coco-Caprylate, Curcuma Longa Extract*, Propanediol, Polyglycery1-6 Distearate, Crataegus Oxyacantha Extract*, Crataegus oxyacantha (hawthorn), Glyceryl Stearate (2%), Nelumbo Nucifera Root Water, Jojoba Esters, Aspalathus Linearis Leaf Extract*, Sodium Stearoyl Glutamate, Polyglyceryl-3 Beeswax, Glycerin, Cetyl Alcohol, Tocopherol (Vitamin E), Salicylic Acid, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Illicium Verum (Anise) Fruit/Seed Oil* , Sorbic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Oil*, Glycogen.

    *Certified organic.

  • Questions or Comments?

    1-800-263-8888



    Outside Canada or the United States dial 514-333-8282 or visit www.nellydevuyst.com

  • NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL (NDC 71447-030-00)

    Nelly Devuys BioMedical Anti-Redness Serum 30 mL

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    TURMERIC (UNII: 856YO1Z64F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)  
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STAR ANISE FRUIT (UNII: CK15HA8438)  
    SORBIC ACID (UNII: X045WJ989B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    GLYCOGEN (UNII: 309GSC92U1)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-030-011 in 1 BOX10/14/2021
    1NDC:71447-030-0030 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/14/2021
    Labeler - LABORATOIRES DRUIDE INC (245815014)
    Registrant - LABORATOIRES DRUIDE INC (245815014)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRES DRUIDE INC245815014manufacture(71447-030)