NELLY DEVUYST MASK BIOACNE- salicylic acid cream 
LABORATOIRES DRUIDE INC

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.

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NELLY DEVUYST MASK BIOACNE 150g

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

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)

Revised: 5/2018
Document Id: 6d1eebb2-6f32-b2ed-e053-2991aa0a5053
Set id: 6a12d49b-67f3-6fd7-e053-2991aa0a48c9
Version: 2
Effective Time: 20180526
 
LABORATOIRES DRUIDE INC