Label: NELLY DEVUYST PH TONER BIOACNE- salicylic acid liquid

  • 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 May 26, 2018

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

  • DRUG FACTS

  • Active Ingredients

    Salicylic Acid 0.5%

  • 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 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, after cleansing and or exfoliating, moisten a cotton pad with toner and apply to face and neck using upward movements, avoiding the eye area.

    ▪ 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*, Propanediol, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Pullulan, Silver Citrate, Magnolia Officinalis Bark Extract, Arginine, Salicylic Acid, 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 pH TONER BIOACNE 16.90 FL.OZ (500mL) (71447-007-01)

    Nelly Devuyst pH Toner BioAcne 500 mLpHTonerBioAcneLabel

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST PH TONER BIOACNE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-007
    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
    ARGININE (UNII: 94ZLA3W45F)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    LIME OIL (UNII: UZH29XGA8G)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILVER CITRATE (UNII: CKA421A1J7)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-007-011 in 1 CARTON05/26/2018
    1500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/26/2018
    Labeler - LABORATOIRES DRUIDE INC (245815014)
    Registrant - LABORATOIRES DRUIDE INC (245815014)
    Establishment
    NameAddressID/FEIBusiness Operations
    7774672 CANADA INC203095039pack(71447-007)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRES DRUIDE INC245815014manufacture(71447-007) , label(71447-007)