Label: NELLY DEVUYST MASK BIOACNE- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

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 healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • DRUG FACTS

  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    Dries and helps clear up acne pimples, and allows skin to heal.

  • 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, apply a thin layer to face, let dry five minutes or until mask turns white. After mask has dried, rinse thoroughly. Pat dry with towel. Use 1-2 times per week.

    ▪ If dryness or peeling occurs, reduce frequency of application.

  • Other information

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

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice*, Kaolin, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Silica, Glycerin, Coco-Glycoside, Sea Silt, Zinc Oxide, 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*, Tocopherol, Bentonite, Carrageenan, Sodium Gluconate, Levulinic Acid, Sodium Levulinate, Sodium Carboxymethyl Cellulose, Sodium Anisate, Xanthan Gum, 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 DEVUYST MASK BIOACNE 5.20 OZ. (150g) (71447-005-01)

    Nelly Devuyst Mask BioAcne 150gMaskBioAcneLabel

  • INGREDIENTS AND APPEARANCE
    NELLY DEVUYST MASK BIOACNE 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-005
    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
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SEA SALT (UNII: 87GE52P74G)  
    SILVER CITRATE (UNII: CKA421A1J7)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71447-005-01150 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/26/2018
    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(71447-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRES DRUIDE INC245815014manufacture(71447-005) , label(71447-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!