NELLY DEVUYST PURIFYING BIOACNE- salicylic acid gel

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

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
LABORATOIRES DRUIDE INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment Helps keep skin clear of new acne pimples.
Authorization status:
OTC monograph final
Authorization number:
71447-004-02

NELLY DEVUYST PURIFYING BIOACNE- salicylic acid gel

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 PURIFYING GEL BIOACNE 50g

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?

+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 PURIFYING GEL BIOACNE 1.75.OZ. (50g) (71447-004-02)

NELLY DEVUYST PURIFYING BIOACNE

salicylic acid gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71447-0 0 4

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

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

SILVER CITRATE (UNII: CKA421A1J7)

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

LAVANDIN O IL (UNII: 9 RES347CKG)

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

BENTO NITE (UNII: A3N5ZCN45C)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

LEVULINIC ACID (UNII: RYX5QG6 1EI)

SO DIUM LEVULINATE (UNII: VK44E1MQU8 )

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

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

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

SO DIUM ANISATE (UNII: F9 WFJ28 MV9 )

BETASIZO FIRAN (UNII: 2X51AD1X3T)

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

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

WATER (UNII: 0 59 QF0 KO0 R)

XANTHAN GUM (UNII: TTV12P4NEE)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

LIME O IL (UNII: UZH29 XGA8 G)

TEA TREE O IL (UNII: VIF56 5UC2G)

LAVANDULA ANGUSTIFO LIA FLO WER (UNII: 19 AH1RAF4M)

ZINC O XIDE (UNII: SOI2LOH54Z)

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

ARCTIUM LAPPA RO O T (UNII: 59 7E9 BI3Z3)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:71447-0 0 4-

50 g in 1 TUBE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/26 /20 18

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 IINC

20 30 9 50 39

pa c k(71447-0 0 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LABORATOIRES DRUIDE INC

2458 150 14

manufacture(71447-0 0 4) , label(71447-0 0 4)

Revised: 9/2019

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