NELLY DEVUYST MASK BIOACNE- salicylic acid cream

NELLY DEVUYST MASK BIOACNE by

Drug Labeling and Warnings

NELLY DEVUYST MASK BIOACNE by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES DRUIDE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

+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 MASK BIOACNE 1.73 OZ. (50g) (

71447-005-02)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST MASK BIOACNE 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-005-02	50 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	05/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/26/2018

Labeler - LABORATOIRES DRUIDE INC (245815014)

Registrant - LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Business Operations
7774672 CANADA INC		203095039	pack(71447-005)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-005) , label(71447-005)