Label: NELLY DEVUYST CLEANSING BIOACNE- salicylic acid gel

  • NDC Code(s): 71447-003-01
  • 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 January 1, 2021

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

  • DRUG FACTS

  • Active Ingredients

    Salicylic Acid 0.7%

  • Purpose

    Acne Treatment

  • Uses

    Reduces the number and or severity of 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, product can be used in the morning and or evening.

    ▪ Apply product to wet hands and rub well over entire face.

    ▪ Rinse well with water until all traces of cleanser are removed.

    ▪ 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*, Coco-glucoside, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Glycerin, Silver, 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, Xanthan Gum, Sodium Carboxymethyl Cellulose, Potassium Sorbate, 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 CLEANSING GEL BIOACNE 16.90 FL.OZ (500mL) (71447-003-01)

    Nelly Devuyst Cleansing Gel BioAcne 500mlCleansingGelBioAcneLabel

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST CLEANSING BIOACNE 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIME OIL (UNII: UZH29XGA8G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILVER CITRATE (UNII: CKA421A1J7)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    ARGININE (UNII: 94ZLA3W45F)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-003-011 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
    LABORATOIRES DRUIDE INC245815014manufacture(71447-003) , label(71447-003)