NELLY DEVUYST CLEANSING BIOACNE- salicylic acid gel 
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 CLEANSING GEL BIOACNE 500 mL

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

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)

Revised: 1/2021
Document Id: c792053e-56a4-d83a-e053-2a95a90aeda7
Set id: 69bcce29-8084-9d84-e053-2991aa0a4d00
Version: 3
Effective Time: 20210101
 
LABORATOIRES DRUIDE INC