FDA.reportPublic FDA data

NELLY DEVUYST MICELLAR FOAM BIOACNE

Manufacturer
LABORATOIRES DRUIDE INC
Effective date
2021-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:36

Label at a glance#

ProductNELLY DEVUYST MICELLAR FOAM BIOACNE
Active ingredientSALICYLIC ACID
Label structure13 sections

Indications and uses

Helps prevent new acne pimples from forming.

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, moisten skin with warm water. ▪ Dispense two full pumps of product into palm of hand, apply by gently massaging over the entire affected area, rinse thoroughly and pat dry. ▪ Avoid contact with eyes. If contact occurs, rinse eyes with water. ▪ Because excessive drying of the skin may occur, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Helps prevent new acne pimples from forming.

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, moisten skin with warm water.

▪ Dispense two full pumps of product into palm of hand, apply by gently massaging over the entire affected area, rinse thoroughly and pat dry.

▪ Avoid contact with eyes. If contact occurs, rinse eyes with water.

▪ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

▪ If bothersome dryness, irritation or peeling occurs, reduce application to every other day.

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*, Arctium Lappa Root Extract*, Urtica Dioica (Nettle) Extract*, Lavandula Angustifolia (Lavender) Flower Extract*, Propanediol, Coco-Glucoside, Glycerin, Silver Citrate, Arginine, 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*, Sodium Gluconate, Levulinic Acid, Sodium Levulinate, 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 www.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 MICELLAR FOAM BIOACNE 5.07 FL.OZ (150mL) (71447-008-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MicellarFoamBioAcneLabelMicellarFoamBioAcneLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
865105salicylic acid 0.5 % Medicated Liquid SoapPSN2
865105salicylic acid 5 MG/ML Medicated Liquid SoapSCD2
865105salicylic acid 0.5 % Foaming CleanserSY2
865105salicylic acid 0.5 % MaskSY2
865105salicylic acid 0.5 % Medicated Liquid SoapSY2
865105salicylic acid 0.5 % Topical Gel CleanserSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71447-008-002025-01-30C16284748780-12cef2736-7d8c-d83d-e063-dadaa90ab31fNELLY DEVUYST MICELLAR FOAM BIOACNE 150mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71447-008-00NELLY DEVUYST MICELLAR FOAM BIOACNE150 mL in 1 BOTTLE, PUMPLIQUID1502
71447-008-00NELLY DEVUYST MICELLAR FOAM BIOACNE1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71447-008NELLY DEVUYST MICELLAR FOAM BIOACNE (SALICYLIC ACID) LIQUID [LABORATOIRES DRUIDE INC]2Legacy NDC, 2 package rows20210721_6a3cc545-29b9-1a75-e053-2a91aa0a8f8c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71447-00871447-008-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIME OILUZH29XGA8GIACT
TEA TREE OILVIF565UC2GIACT
SODIUM GLUCONATER6Q3791S76IACT
LEVULINIC ACIDRYX5QG61EIIACT
SODIUM LEVULINATEVK44E1MQU8IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT OIL55DGS3F5YGIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERINPDC6A3C0OXIACT
SILVER CITRATECKA421A1J7IACT
ARGININE94ZLA3W45FIACT
MAGNOLIA OFFICINALIS BARK5M609NV974IACT
PROPANEDIOL5965N8W85TIACT
MICHELIA ALBA LEAF OIL002RK9L1FNIACT
LAVANDIN OIL9RES347CKGIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT

Source Document#

Source XML · Source PDF

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
c791089f-f86f-f1d4-e053-2995a90ad8446a3cc545-29b9-1a75-e053-2a91aa0a8f8c2021-01-01WarningsExact identifier
spl id: c791089f-f86f-f1d4-e053-2995a90ad844
spl set id: 6a3cc545-29b9-1a75-e053-2a91aa0a8f8c

Reported adverse events (FAERS/openFDA)#

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