Label: NELLY DEVUYST SERUM BIOACNE- salicylic acid liquid

  • NDC Code(s): 71447-006-00
  • 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

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  • DRUG FACTS

  • Active Ingredients

    Salicylic acid

  • Purpose

    Acne Treatment

  • Uses

    Penetrates pores to control or reduce acne pimples.

  • 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

    ▪ 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

    ▪ Cleanse skin thoroughly before applying the product.

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

    ▪ If no discomfort occurs, cover the entire affected area with a thin layer.

    ▪ Start with one application daily, then gradually increase to two or three times daily, if needed.

    ▪ If dryness or peeling occurs, reduce application to once a day or every other day.

  • Other information

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

  • Inactive Ingredients

    Thymus Vulgaris (Thyme) Extract*, Alcohol, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Silver Citrate, 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*, Arginine, 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 wwww.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 DEVUST SERUM BIOACNE 0.5 FL.OZ (15mL) (71447-006-00)

    SerumBioAcneLabel

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST SERUM BIOACNE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SILVER CITRATE (UNII: CKA421A1J7)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    WATER (UNII: 059QF0KO0R)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    ALCOHOL (UNII: 3K9958V90M)  
    LIME OIL (UNII: UZH29XGA8G)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    ARGININE (UNII: 94ZLA3W45F)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-006-002 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/20/2018
    Labeler - LABORATOIRES DRUIDE INC (245815014)
    Registrant - LABORATOIRES DRUIDE INC (245815014)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Druide Inc245815014manufacture(71447-006) , label(71447-006)
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