NELLY DEVUYST MICELLAR FOAM BIOACNE- salicylic acid liquid

NELLY DEVUYST MICELLAR FOAM BIOACNE by

Drug Labeling and Warnings

NELLY DEVUYST MICELLAR FOAM 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 0.5%

Purpose

Acne Treatment

Uses

Helps prevent new acne pimples from forming.

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, moisten skin with warm water.

▪ Dispense two full pumps of product into palm of hand, apply by gently massaging over the entire affected area, rinse thoroughly and pat dry.

▪ Avoid contact with eyes. If contact occurs, rinse eyes with water.

▪ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

▪ 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*, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Coco-Glucoside, Glycerin, Silver Citrate, Arginine, 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*, Sodium Gluconate, Levulinic Acid, Sodium Levulinate, 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 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 MICELLAR FOAM BIOACNE 5.07 FL.OZ (150mL) (

71447-008-00)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST MICELLAR FOAM BIOACNE 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERIN (UNII: PDC6A3C0OX)
SILVER CITRATE (UNII: CKA421A1J7)
ARGININE (UNII: 94ZLA3W45F)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
PROPANEDIOL (UNII: 5965N8W85T)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
LAVANDIN OIL (UNII: 9RES347CKG)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
LIME OIL (UNII: UZH29XGA8G)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM GLUCONATE (UNII: R6Q3791S76)
LEVULINIC ACID (UNII: RYX5QG61EI)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-008-00	1 in 1 CARTON	04/25/2018
1		150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/25/2018

Labeler - LABORATOIRES DRUIDE INC (245815014)

Registrant - LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Business Operations
7774672 CANADA INC		203095039	pack(71447-008)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-008) , label(71447-008)