FDA.reportPublic FDA data

PURE NERIUM ACNE THERAPY CREAM

Manufacturer
Nerium SkinCare, Inc.
Effective date
2019-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:43

Label at a glance#

ProductPURE NERIUM ACNE THERAPY
Active ingredientSALICYLIC ACID
Label structure12 sections

Storage and handling

Transport and store in a cool dry place and keep away from direct sunlight.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Acne Treatment Cream

OTC - ACTIVE INGREDIENT SECTION


Salicylic acid 2.0%.

INDICATIONS & USAGE SECTION


• For the treatment of acne.
• Dries and clears acne blemishes, acne pimples, blackheads, whiteheads and allows skin to heal.
• Penetrates pores to control acne blemishes, acne pimples, blackheads, whiteheads.
• Helps keep skin clear of new acne blemishes, acne pimples, blackheads, whiteheads.

WARNINGS SECTION


For external use only.​

OTC - WHEN USING SECTION


When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

INSTRUCTIONS FOR USE SECTION


• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected ares during the first 3 days. If no discomfort occurs, follow the directions stated above.

OTHER SAFETY INFORMATION


Not recommended for use by pregnant or nursing women.

STORAGE AND HANDLING SECTION


Transport and store in a cool dry place and keep away from direct sunlight.

INACTIVE INGREDIENT SECTION


Aloe Barbadensis Leaf Juice, Nerium Oleander Leaf Extract (NAE8®), Water (Aqua), Propanediol, Hydrolyzed Egg Shell Membrane (Peptide Matrix – Collagen & Elastin), Cetyl Alcohol, Glycerin, Glyceryl Stearate, Potassium Cetyl Phosphate, Cetearyl Olivate, Caprylic/Capric Triglyceride, Dimethicone, Ricinus Communis (Castor) Seed Oil, Glyceryl Caprylate, Sorbitan Olivate, Lysolecithin, Sclerotium Gum, Xanthan Gum, Allantoin, Arginine, Avena Sativa Kernel Flour (Colloidal Oatmeal), Butyrospermum Parkii (Shea) Butter, Olea Europaea (Olive) Fruit Oil, Pelargonium Graveolens (Geranium) Flower Oil, Tocopherol, Fragrance, Leuconostoc/Radish Root Ferment Filtrate, Pullulan, Ocimum Basilicum (Basil) Extract, Linum Usitatissimum (Linseed) Seed Oil, Carum Petroselinum (Parsley) Extract, Benzyl Alcohol, Potassium Sorbate, Dipotassium Glycyrrhizate, Glyceryl Undecylenate, Sea Salt, Mahonia Aquifolium (Oregon Grape) Root Extract, Sodium Benzoate, Muriella Aurantiaca/Ruttnera Lamellosa Oil (Plankton Extract), Citric Acid, Lecithin

OTC - QUESTIONS SECTION


1-(844)-599-7787 M-F (9 am to 5 pm CST)

DOSAGE & ADMINISTRATION SECTION

2% Topical Cream

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURE
NERIUM®

ACNE
THERAPY CREAM
WITH SALICYLIC ACID

PATENTED
NERIUM ALOE
EXTRACT

NAE-8®

PURE NERIUM® -ACNE THERAPY CREAM, 30.3g/1.07 FL.OZ.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30.3g/1.07FL.OZ.30.3g/1.07FL.OZ.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN1
317152salicylic acid 20 MG/ML Topical CreamSCD1
317152salicylic acid 2 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72216-227-322021-01-29C16284748780-1ba0f9c33-1f28-a910-e053-dadaa90a0b85PURE NERIUM ACNE THERAPY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72216-227-13PURE NERIUM ACNE THERAPY30.3 g in 1 BOTTLE, PUMPCREAM30.31
72216-227-32PURE NERIUM ACNE THERAPY1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72216-227PURE NERIUM ACNE THERAPY (SALICYLIC ACID 2.0%) CREAM [NERIUM SKINCARE, INC.]1Legacy NDC, 2 package rows20191004_940a2e5d-f348-5398-e053-2995a90acc08.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72216-22772216-227-13, 72216-227-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
PULLULAN8ZQ0AYU1TTIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
NERIUM OLEANDER LEAF7KV510R6H6IACT
WATER059QF0KO0RIACT
BETASIZOFIRAN2X51AD1X3TIACT
XANTHAN GUMTTV12P4NEEIACT
OATMEAL8PI54V663YIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
SALICYLIC ACIDO414PZ4LPZACTIB
EGG SHELL MEMBRANEN7QBR4212VIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CETEARYL OLIVATE58B69Q84JOIACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
MAHONIA AQUIFOLIUM ROOT746TB9VNDPIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
OCIMUM BASILICUM WHOLEP4815JL4O3IACT
PROPANEDIOL5965N8W85TIACT
LINSEED OIL84XB4DV00WIACT
PARSLEY58FMD0Q0EVIACT
BENZYL ALCOHOLLKG8494WBHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SEA SALT87GE52P74GIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN OLIVATEMDL271E3GRIACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANCQD833204ZIACT
ALLANTOIN344S277G0ZIACT
ARGININE94ZLA3W45FIACT
OLIVE OIL6UYK2W1W1EIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
940a2edc-ab2e-fb8a-e053-2a95a90a89b4940a2e5d-f348-5398-e053-2995a90acc082019-10-03WarningsExact identifier
spl id: 940a2edc-ab2e-fb8a-e053-2a95a90a89b4
spl set id: 940a2e5d-f348-5398-e053-2995a90acc08

Reported adverse events (FAERS/openFDA)#

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