Label: NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS 50G- colloidal oatmeal gel

  • 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 January 1, 2022

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  • 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*, Arnica Montana Flower Extract*, Hypericum Perforatum Extract*, Propanediol, Octyldodecyl Myristate, Capparis Spinosa Fruit Extract, Xanthan Gum, Nelumbo Nucifera Root Water, Alpha-Glucan Oligosaccharide, Salicylic Acid, Glycerin (vegetal), Benzyl Alcohol, Aqua (Water), Sorbic Acid, Potassium Sorbate, Aesculus Hippocastanum (Horse Chestnut) Extract*, Parfum (Natural), Tocopherol (Vitamin E), Fructose, Inulin, Bisabolol.

    *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 GEL 50G (NDC 71447-053-00)

    Nelly Devuys BioAcne Anti-Redness Gel

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS 50G 
    colloidal oatmeal gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-053
    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
    LEVOMENOL (UNII: 24WE03BX2T)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAPER BERRY (UNII: 7G4C45EE8C)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBIC ACID (UNII: X045WJ989B)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    WATER (UNII: 059QF0KO0R)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
    INULIN (UNII: JOS53KRJ01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-053-0050 g in 1 TUBE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2022
    Labeler - LABORATOIRES DRUIDE INC (245815014)
    Registrant - LABORATOIRES DRUIDE INC (245815014)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRES DRUIDE INC245815014manufacture(71447-053)
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