FDA.reportPublic FDA data

Alba Botanica Fast Fix for Pimple

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:53

Label at a glance#

ProductAlba Botanica Fast Fix for Pimple
Active ingredientSULFUR
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sulfur 6.0%

DOSAGE & ADMINISTRATION SECTION

Using finger, dab tiny amount on blemishand gently tap to cover with thin layer. For more coverage allow to dry and repeat. Use alone, over or under makeup.

OTC - PURPOSE SECTION

Acne Treatment

WARNINGS SECTION

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness and irritation of the skin. If this occurs, only one drug should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, flush throughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

INACTIVE INGREDIENT SECTION

Water, Isoamyl Laurate, Caprylic/Capric Triglyceride, Titanium Dioxide (CI77891), Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Alba (Willow) Bark Extract (1), Alcohol (1), Alumina, Stearyl Alcohol, Cetyl Alcohol, Citric Acid, Glycerin, Jojoba Ester, Saccharomyces Ferment, Silica, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI77491).

(1) Certified Organicf Ingredient;

INDICATIONS & USAGE SECTION

For the treatment of acne.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FB labelFB label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417462sulfur 6 % Topical CreamPSN3
417462sulfur 60 MG/ML Topical CreamSCD3
417462sulfur 6 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2796-12023-01-30C16284748780-1ba0f9c33-28e1-a910-e053-dadaa90a0b85Alba Botanica Fast Fix for Pimples
61995-2796-12021-02-05C16284748780-1ba0f9c33-28e1-a910-e053-dadaa90a0b85Alba Botanica Fast Fix for Pimples
61995-2796-12021-01-29C16284748780-1ba0f9c33-28e1-a910-e053-dadaa90a0b85Alba Botanica Fast Fix for Pimples

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2796-1Alba Botanica Fast Fix for Pimple30 g in 1 PACKETCREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2796ALBA BOTANICA FAST FIX FOR PIMPLE (SULFUR) CREAM [THE HAIN CELESTIAL GROUP, INC.]3Legacy NDC, 1 package rows20210207_68582c00-9de8-380e-e053-2991aa0a2197.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
61995-279661995-2796-1

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
SILICON DIOXIDEETJ7Z6XBU4IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SALIX ALBA BARK205MXS71H7IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
BROWN IRON OXIDE1N032N7MFOIACT
ISOAMYL LAURATEM1SLX00M3MIACT
SORBITOL506T60A25RIACT
ALCOHOL3K9958V90MIACT
ALUMINUM OXIDELMI26O6933IACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
BENZYL ALCOHOLLKG8494WBHIACT
SULFUR70FD1KFU70ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL ALCOHOL936JST6JCNIACT

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
ba9f9889-89e9-141a-e053-2995a90a9e9b68582c00-9de8-380e-e053-2991aa0a21972021-02-05WarningsExact identifier
spl id: ba9f9889-89e9-141a-e053-2995a90a9e9b
spl set id: 68582c00-9de8-380e-e053-2991aa0a2197

Reported adverse events (FAERS/openFDA)#

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