NELLY DEVUYST PURIFYING BIOACNE- salicylic acid gel

NELLY DEVUYST PURIFYING BIOACNE by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

Helps keep skin clear of new 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

▪ 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

Aloe Barbadensis Leaf Juice*, Propanediol, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Glycerin, 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*, Bentonite, Carrageenan, Sodium Gluconate, Levulinic Acid, Sodium Levulinate, Sodium Carboxymethyl Cellulose, Sodium Anisate, Sclerotium Gum, Xanthan Gum, Tocopherol, Citric Acid, 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 wwww.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 PURIFYING GEL BIOACNE 5.20.OZ. (150g)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST PURIFYING BIOACNE 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-004
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
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
SILVER CITRATE (UNII: CKA421A1J7)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
LAVANDIN OIL (UNII: 9RES347CKG)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
BENTONITE (UNII: A3N5ZCN45C)
CARRAGEENAN (UNII: 5C69YCD2YJ)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUCONATE (UNII: R6Q3791S76)
LEVULINIC ACID (UNII: RYX5QG61EI)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
PROPANEDIOL (UNII: 5965N8W85T)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM ANISATE (UNII: F9WFJ28MV9)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
LIME OIL (UNII: UZH29XGA8G)
TEA TREE OIL (UNII: VIF565UC2G)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-004-01	150 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 IINC		203095039	pack(71447-004)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-004) , label(71447-004)