FDA.reportPublic FDA data

SIMPLY VITAL Acne Face Cream

Manufacturer
ALPHA PLANTS INC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:08

Label at a glance#

ProductSIMPLY VITAL Acne Face Cream
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

for the treatment of acne

Dosage and administration

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 appilcation daily, then gradually increase to two or three times daily if needed or as directed by a doctor. if bothersome dryness or peeling occur, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses:

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings:

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION 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 appilcation daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occur, reduce application to once a day or every other day.

Other information:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Deionized Water, Butylene Glycol, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Dimethicone, Dodecane, Echinacea Purpurea (Coneflower) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Polysorbate-20, Pyrus Malus (Apple Cider Vinegar), Sodium Hydroxide, Sodium PCA, Cymbopogon Schoenanthus (Lemongrass) Oil, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

+1 (205) 624-9177  

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN2
317152salicylic acid 20 MG/ML Topical CreamSCD2
317152salicylic acid 2 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82460-272-00SIMPLY VITAL Acne Face Cream60 mL in 1 JARCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82460-272SIMPLY VITAL ACNE FACE CREAM (SALICYLIC ACID) CREAM [ALPHA PLANTS INC]2Current NDC, Legacy NDC, 1 package rows20231112_67c43d4a-873c-4b8e-83ff-6485d9633e7b.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82460-27282460-272-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
DODECANE11A386X1QHIACT
ECHINACEA PURPUREA WHOLEQI7G114Y98IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
APPLE CIDER VINEGAR0UE22Q87VCIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
CYMBOPOGON SCHOENANTHUS OILXE7K568ILOIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
ndc (package): 82460-272-00
ndc (product): 82460-272
ndc11 (package): 82460027200
spl id: 09e31e63-21b9-2c4d-e063-6294a90a3d86
spl set id: 67c43d4a-873c-4b8e-83ff-6485d9633e7b

Reported adverse events (FAERS/openFDA)#

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