FDA.reportPublic FDA data

NELLY DEVUYST MASK BIOACNE

Manufacturer
LABORATOIRES DRUIDE INC | 7774672 CANADA INC
Effective date
2018-05-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:41

Label at a glance#

ProductNELLY DEVUYST MASK BIOACNE
Active ingredientSALICYLIC ACID
Label structure13 sections

Indications and uses

Dries and helps clear up acne pimples, and allows skin to heal.

Dosage and administration

▪ For new users: apply product to a small area once to test if you are sensitive to this product. ▪ If no discomfort occurs, apply a thin layer to face, let dry five minutes or until mask turns white. After mask has dried, rinse thoroughly. Pat dry with towel. Use 1-2 times per week. ▪ If dryness or peeling occurs, reduce frequency of application.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Dries and helps clear up acne pimples, and allows skin to heal.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

▪ 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.

and ask a doctor if

OTC - ASK DOCTOR SECTION

▪ 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

▪ If no discomfort occurs, apply a thin layer to face, let dry five minutes or until mask turns white. After mask has dried, rinse thoroughly. Pat dry with towel. Use 1-2 times per week.

▪ If dryness or peeling occurs, reduce frequency of application.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice*, Kaolin, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Silica, Glycerin, Coco-Glycoside, Sea Silt, 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*, Tocopherol, Bentonite, Carrageenan, Sodium Gluconate, Levulinic Acid, Sodium Levulinate, Sodium Carboxymethyl Cellulose, Sodium Anisate, Xanthan Gum, Potassium Sorbate, Citric Acid, Aqua.

Certified organic*

Questions or Comments?

OTC - QUESTIONS SECTION

Call +1 800-263-8888

Outside Canada or United States, dial +1 514-333-8282, or visit wwww.nellydevuyst.com

Distributed By

SPL UNCLASSIFIED SECTION

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 MASK BIOACNE 5.20 OZ. (150g) (71447-005-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nelly Devuyst Mask BioAcne 150gNelly Devuyst Mask BioAcne 150gMaskBioAcneLabelMaskBioAcneLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN2
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD2
562600salicylic acid 2 % Facial Cleanser TonerSY2
562600salicylic acid 2 % Facial ScrubSY2
562600salicylic acid 2 % Medicated Liquid SoapSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130829852198129GTIN-13: 0829852198129
EAN-13: 0829852198129
GTIN-12: 829852198129
UPC-A: 829852198129
GTIN storage (14 digits): 00829852198129		Mask-BioAcne-150g.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71447-005-012021-07-23C16284748780-1c7ccaba7-1956-fd44-e053-dadaa90aa01bNELLY DEVUYST MASK BIOACNE 150g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71447-005-01NELLY DEVUYST MASK BIOACNE150 g in 1 TUBE, WITH APPLICATORCREAM1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71447-005NELLY DEVUYST MASK BIOACNE (SALICYLIC ACID) CREAM [LABORATOIRES DRUIDE INC]2Legacy NDC, 1 package rows20180526_6a12d49b-67f3-6fd7-e053-2991aa0a48c9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71447-00571447-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZIACT
LAVANDIN OIL9RES347CKGIACT
TEA TREE OILVIF565UC2GIACT
MICHELIA ALBA LEAF OIL002RK9L1FNIACT
CITRUS AURANTIIFOLIA FRUIT OIL7937R189CBIACT
ALOE VERA LEAFZY81Z83H0XIACT
KAOLIN24H4NWX5COIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
BENTONITEA3N5ZCN45CIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SEA SALT87GE52P74GIACT
SILVER CITRATECKA421A1J7IACT
MAGNOLIA OFFICINALIS BARK5M609NV974IACT
TOCOPHEROLR0ZB2556P8IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM GLUCONATER6Q3791S76IACT
LEVULINIC ACIDRYX5QG61EIIACT
SODIUM LEVULINATEVK44E1MQU8IACT
SALICYLIC ACIDO414PZ4LPZACTIB
URTICA DIOICA LEAFX6M0DRN46QIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
PROPANEDIOL5965N8W85TIACT
ARCTIUM LAPPA ROOT OIL55DGS3F5YGIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
COCO GLUCOSIDEICS790225BIACT
SODIUM ANISATEF9WFJ28MV9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6d1eebb2-6f32-b2ed-e053-2991aa0a50536a12d49b-67f3-6fd7-e053-2991aa0a48c92018-05-26WarningsExact identifier
spl id: 6d1eebb2-6f32-b2ed-e053-2991aa0a5053
spl set id: 6a12d49b-67f3-6fd7-e053-2991aa0a48c9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.