NELLY DEVUYST PH TONER BIOACNE- salicylic acid liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Salicylic Acid 0.5%
Available from:
LABORATOIRES DRUIDE INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment Penetrates pores to control or reduce acne pimples.
Authorization status:
OTC monograph final
Authorization number:
71447-007-02

NELLY DEVUYST PH TONER BIOACNE- salicylic acid liquid

LABORATOIRES DRUIDE INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

NELLY DEVUYST pH TONER BIOACNE 100mL

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?

+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 3.38 FL.OZ (100mL) (71447-007-02)

NELLY DEVUYST PH TONER BIOACNE

salicylic acid liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71447-0 0 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

0 .5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ARGININE (UNII: 9 4ZLA3W45F)

MICHELIA ALBA LEAF O IL (UNII: 0 0 2RK9 L1FN)

LIME O IL (UNII: UZH29 XGA8 G)

LAVANDIN O IL (UNII: 9 RES347CKG)

CITRUS AURANTIUM FRUIT O IL (UNII: 59 JDQ5VT0 T)

SO DIUM GLUCO NATE (UNII: R6 Q379 1S76 )

LEVULINIC ACID (UNII: RYX5QG6 1EI)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

MAGNO LIA O FFICINALIS BARK (UNII: 5M6 0 9 NV9 74)

GLYCERIN (UNII: PDC6 A3C0 OX)

LAVANDULA ANGUSTIFO LIA FLO WER (UNII: 19 AH1RAF4M)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SILVER CITRATE (UNII: CKA421A1J7)

PULLULAN (UNII: 8 ZQ0 AYU1TT)

TEA TREE O IL (UNII: VIF56 5UC2G)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

ARCTIUM LAPPA RO O T O IL (UNII: 55DGS3F5YG)

URTICA DIO ICA LEAF (UNII: X6 M0 DRN46 Q)

SO DIUM LEVULINATE (UNII: VK44E1MQU8 )

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:71447-0 0 7-

1 in 1 CARTON

0 5/26 /20 18

1

10 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 5/26 /20 18

LABORATOIRES DRUIDE INC

Labeler -

LABORAT OIRES DRUIDE INC (245815014)

Registrant -

LABORAT OIRES DRUIDE INC (245815014)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

77746 72 CANADA INC

20 30 9 50 39

pa c k(71447-0 0 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LABORATOIRES DRUIDE INC

2458 150 14

manufacture(71447-0 0 7) , label(71447-0 0 7)

Revised: 9/2019

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