NELLY DEVUYST PH TONER BIOACNE- salicylic acid liquid

NELLY DEVUYST pH TONER BIOACNE by

Drug Labeling and Warnings

NELLY DEVUYST pH TONER 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 0.5%

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 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, after cleansing and or exfoliating, moisten a cotton pad with toner and apply to face and neck using upward movements, avoiding the eye area.

▪ 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*, Propanediol, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Pullulan, Silver Citrate, 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, 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 pH TONER BIOACNE 16.90 FL.OZ (500mL) (

71447-007-01)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST PH TONER BIOACNE 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-007
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
ARGININE (UNII: 94ZLA3W45F)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
LIME OIL (UNII: UZH29XGA8G)
LAVANDIN OIL (UNII: 9RES347CKG)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
LEVULINIC ACID (UNII: RYX5QG61EI)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
GLYCERIN (UNII: PDC6A3C0OX)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILVER CITRATE (UNII: CKA421A1J7)
PULLULAN (UNII: 8ZQ0AYU1TT)
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
ARCTIUM LAPPA ROOT OIL (UNII: 55DGS3F5YG)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-007-01	1 in 1 CARTON	05/26/2018
1		500 mL in 1 BOTTLE, SPRAY; 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(71447-007)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-007) , label(71447-007)