FDA.reportPublic FDA data

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL

Manufacturer
LABORATOIRES DRUIDE INC
Effective date
2021-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:18

Label at a glance#

ProductNELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL
Active ingredientOATMEAL
Label structure13 sections

Indications and uses

▪ Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Dosage and administration

▪ Apply to affected area as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.3%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

▪ Temporarily protects and helps relieve minor skin irritations and itching due to eczema rash and dermatitis.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Consult a healthcare practitioner if symptoms worsen or last for more than 7 days.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

▪ Apply to affected area as needed.

Other Information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun. Store the product at room temperature 20 to 25°C (68 to 77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice*, C10-18 Triglycerides, Oenothera Biennis (Evening Primrose) Oil*, Coco-Caprylate, Curcuma Longa Extract*, Propanediol, Polyglycery1-6 Distearate, Crataegus Oxyacantha Extract*, Crataegus oxyacantha (hawthorn), Glyceryl Stearate (2%), Nelumbo Nucifera Root Water, Jojoba Esters, Aspalathus Linearis Leaf Extract*, Sodium Stearoyl Glutamate, Polyglyceryl-3 Beeswax, Glycerin, Cetyl Alcohol, Tocopherol (Vitamin E), Salicylic Acid, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Illicium Verum (Anise) Fruit/Seed Oil* , Sorbic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil*, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Oil*, Glycogen.

*Certified organic.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-263-8888



Outside Canada or the United States dial 514-333-8282 or visit www.nellydevuyst.com

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL (NDC 71447-030-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nelly Devuys BioMedical Anti-Redness Serum 30 mLNelly Devuys BioMedical Anti-Redness Serum 30 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2559963colloidal oatmeal 1.3 % Topical CreamPSN1
2559963colloidal oatmeal 13 MG/ML Topical CreamSCD1
2559963colloidal oatmeal 1.3 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71447-030-012025-01-30C16284748780-12cef2736-801f-d83d-e063-dadaa90ab31fNELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71447-030-00NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL30 g in 1 TUBECREAM301
71447-030-01NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 mL1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71447-030NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS SERUM 30 ML (COLLOIDAL OATMEAL) CREAM [LABORATOIRES DRUIDE INC]1Legacy NDC, 2 package rows20211019_ce9fa5a8-dabd-6b55-e053-2995a90ae7c0.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71447-03071447-030-00, 71447-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO-CAPRYLATE4828G836N6IACT
TURMERIC856YO1Z64FIACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-6 DISTEARATEZ35I17EQOPIACT
HAWTHORN LEAF WITH FLOWER6OM09RPY36IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
NELUMBO NUCIFERA ROOT OIL382005USDHIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
TOCOPHEROLR0ZB2556P8IACT
SALICYLIC ACIDO414PZ4LPZIACT
XANTHAN GUMTTV12P4NEEIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STAR ANISE FRUITCK15HA8438IACT
SORBIC ACIDX045WJ989BIACT
TEA TREE OILVIF565UC2GIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GINGER OILSAS9Z1SVUKIACT
GLYCOGEN309GSC92U1IACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
OATMEAL8PI54V663YACTIB

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
ce9fa5a8-dabe-6b55-e053-2995a90ae7c0ce9fa5a8-dabd-6b55-e053-2995a90ae7c02021-10-14WarningsExact identifier
spl id: ce9fa5a8-dabe-6b55-e053-2995a90ae7c0
spl set id: ce9fa5a8-dabd-6b55-e053-2995a90ae7c0

Reported adverse events (FAERS/openFDA)#

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