NELLY DEVUYST SERUM BIOACNE- salicylic acid liquid

NELLY DEVUYST SERUM BIOACNE by

Drug Labeling and Warnings

NELLY DEVUYST SERUM BIOACNE by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES DRUIDE INC, 7774672 CANADA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

Penetrates pores to control or reduce 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

▪ 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

▪ Cleanse skin thoroughly before applying the product.

▪ For new users: apply product to a small area once a day for three days to test if you are sensitive to this product.

▪ If no discomfort occurs, cover the entire affected area with a thin layer.

▪ Start with one application daily, then gradually increase to two or three times daily, if needed.

▪ If dryness or peeling occurs, reduce application to once a day or every other day.

Other information

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

Inactive Ingredients

Thymus Vulgaris (Thyme) Extract*, Alcohol, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, 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*, Arginine, 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 SERUM BIOACNE 3.30 FL.OZ (100mL) (

71447-009-01)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST SERUM BIOACNE 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-009
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 mL

Inactive Ingredients
Ingredient Name	Strength
LEVULINIC ACID (UNII: RYX5QG61EI)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPANEDIOL (UNII: 5965N8W85T)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
WATER (UNII: 059QF0KO0R)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
LAVANDIN OIL (UNII: 9RES347CKG)
ALCOHOL (UNII: 3K9958V90M)
LIME OIL (UNII: UZH29XGA8G)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
ARGININE (UNII: 94ZLA3W45F)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
TEA TREE OIL (UNII: VIF565UC2G)
SILVER CITRATE (UNII: CKA421A1J7)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-009-01	1 in 1 CARTON	05/26/2018
1		100 mL in 1 BOTTLE, GLASS; 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	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(71447-009)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-009) , label(71447-009)