Label: NELLY DEVUYST MICELLAR FOAM BIOACNE- salicylic acid liquid

  • NDC Code(s): 71447-008-00
  • 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 January 1, 2021

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

  • DRUG FACTS

  • Active Ingredients

    Salicylic acid 0.5%

  • Purpose

    Acne Treatment

  • Uses

    Helps prevent new acne pimples from forming.

  • Warnings

    For external use only.

  • When using this product

    ▪ avoid contact with eyes. If contact occurs, rinse thoroughly with water ▪ Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one product at a time.

  • Stop use

  • and ask a doctor if

    ▪ you develop severe irritation, burning or itching of the skin ▪ for more severe cases and or if improvement is not apparent within 6 to 8 weeks ▪ If you develop hives, swelling of eyes and mouth, blistering or difficulty breathing, get medical help right away.

  • Keep out of reach of children.

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

  • Directions

    ▪ For new users: apply product to a small area once to test if you are sensitive to this product.

    ▪ If no discomfort occurs, moisten skin with warm water.

    ▪ Dispense two full pumps of product into palm of hand, apply by gently massaging over the entire affected area, rinse thoroughly and pat dry.

    ▪ Avoid contact with eyes. If contact occurs, rinse eyes with water.

    ▪ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

    ▪ If bothersome dryness, irritation or peeling occurs, reduce application to every other day.

  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice*, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Coco-Glucoside, Glycerin, Silver Citrate, Arginine, Magnolia Officinalis Bark Extract, Michelia Alba Flower Oil, Citrus Aurantifolia (Lime) Oil*, Lavandula Hybrida Oil*, Tea Tree Leaf Oil*, Citrus Aurantium Dulcis (Orange) Peel Oil Expressed*, Sodium Gluconate, Levulinic Acid, Sodium Levulinate, Potassium Sorbate, Citric Acid, Aqua.

    Certified organic*

  • Questions or Comments?

    Call +1 800-263-8888

    Outside Canada or United States, dial +1 514-333-8282, or visit www.nellydevuyst.com

  • Distributed By

    7774672 Canada Inc (Derme & Co)

    4980 Chemin Bois Franc

    St. Laurent, QC H4S 1A7

    Canada

    +1 514-333-8282, +1 800-263-8888

    www.nellydevuyst.com

    Made in Canada

  • NELLY DEVUYST MICELLAR FOAM BIOACNE 5.07 FL.OZ (150mL) (71447-008-00)

    MicellarFoamBioAcneLabel

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST MICELLAR FOAM BIOACNE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIME OIL (UNII: UZH29XGA8G)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILVER CITRATE (UNII: CKA421A1J7)  
    ARGININE (UNII: 94ZLA3W45F)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-008-001 in 1 CARTON04/25/2018
    1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/25/2018
    Labeler - LABORATOIRES DRUIDE INC (245815014)
    Registrant - LABORATOIRES DRUIDE INC (245815014)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRES DRUIDE INC245815014manufacture(71447-008) , label(71447-008)