FDA.reportPublic FDA data

NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS GEL 50 G

Manufacturer
LABORATOIRES DRUIDE INC
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:47:47

Label at a glance#

ProductNELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS 50G
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*, Arnica Montana Flower Extract*, Hypericum Perforatum Extract*, Propanediol, Octyldodecyl Myristate, Capparis Spinosa Fruit Extract, Xanthan Gum, Nelumbo Nucifera Root Water, Alpha-Glucan Oligosaccharide, Salicylic Acid, Glycerin (vegetal), Benzyl Alcohol, Aqua (Water), Sorbic Acid, Potassium Sorbate, Aesculus Hippocastanum (Horse Chestnut) Extract*, Parfum (Natural), Tocopherol (Vitamin E), Fructose, Inulin, Bisabolol.

*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 GEL 50G (NDC 71447-053-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nelly Devuys BioAcne Anti-Redness GelNelly Devuys BioAcne Anti-Redness Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2590666colloidal oatmeal 1.3 % Topical GelPSN1
2590666colloidal oatmeal 0.013 MG/MG Topical GelSCD1
2590666colloidal oatmeal 1.3 % Topical GelSY1

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
71447-053-002024-01-30C16284748780-11030e365-4c6a-111a-e063-dadaa90a10e2NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS GEL 50 G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71447-053-00NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS 50G50 g in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71447-053NELLY DEVUYST BIO MEDICAL BIOACNE ANTI-REDNESS 50G (COLLOIDAL OATMEAL) GEL [LABORATOIRES DRUIDE INC]1Legacy NDC, 1 package rows20220130_d6c04926-0789-9c9d-e053-2995a90aa124.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71447-05371447-053-00

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
LEVOMENOL24WE03BX2TIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAPER BERRY7G4C45EE8CIACT
PROPANEDIOL5965N8W85TIACT
NELUMBO NUCIFERA ROOT OIL382005USDHIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
SALICYLIC ACIDO414PZ4LPZIACT
XANTHAN GUMTTV12P4NEEIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SORBIC ACIDX045WJ989BIACT
OATMEAL8PI54V663YACTIB
LAVENDER OILZBP1YXW0H8IACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
WATER059QF0KO0RIACT
HORSE CHESTNUT3C18L6RJAZIACT
FRUCTOSE6YSS42VSEVIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
OCTYLDODECYL MYRISTATES013N99GR8IACT
INULINJOS53KRJ01IACT

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
d6c04c77-2670-147b-e053-2a95a90a4b26d6c04926-0789-9c9d-e053-2995a90aa1242022-01-01WarningsExact identifier
spl id: d6c04c77-2670-147b-e053-2a95a90a4b26
spl set id: d6c04926-0789-9c9d-e053-2995a90aa124

Reported adverse events (FAERS/openFDA)#

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