FDA.reportPublic FDA data

Alba Natural Acnedote Astringent

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:16:25

Label at a glance#

ProductAlba Natural Acnedote Astringent
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

INDICATIONS & USAGE SECTION

                               USE

  • For the treatment of acne
  • Apply with a cotton ball to freshly cleansed face morning an evening
  • For the best results, follow with Alba Botanica Natural ACNEdote Invisible Treatment Gel.

WARNINGS

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 or 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 thoroughly with water.

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

QUESTIONS?

OTC - QUESTIONS SECTION

Call (888) 659-7730 or visit www.AlbaBotanica.com

The Hain Celestial Group, Inc.

INACTIVE INGREDIENT SECTION

ILIL

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0% w/w

DOSAGE & ADMINISTRATION SECTION

Lotion

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Controls Acne

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2753-62024-07-31C16284748780-1956f9ecf-d839-621f-e053-dbdaa90a74adAL00763 Alba Natural Acnedote Astringent. IL per label artwork.
61995-2753-62024-07-30C16284748780-1956f9ecf-d839-621f-e053-dbdaa90a74adAL00763 Alba Natural Acnedote Astringent. IL per label artwork.
61995-2763-62023-12-21C16284748780-1956f9ecf-d839-621f-e053-dbdaa90a74adAL00763 Alba Natural Acnedote Astringent. IL per label artwork.
61995-2763-62019-10-21C16284748780-1956f9ecf-d839-621f-e053-dbdaa90a74adAL00763 Alba Natural Acnedote Astringent. IL per label artwork.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2753-6Alba Natural Acnedote Astringent177 g in 1 BOTTLELOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2753ALBA NATURAL ACNEDOTE ASTRINGENT (SALICYLIC ACID) LOTION [THE HAIN CELESTIAL GROUP, INC.]5Current NDC, 1 package rows20240802_939f90e7-e1de-4ca3-a484-90f1b87797d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-275361995-2753-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
WATER059QF0KO0RIACT
MYRICA ESCULENTA FRUITJKM8M5F55DIACT
LINALOOL, (+)-F4VNO44C09IACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALCOHOL 95%7528N5H79BIACT
ORANGE PEELTI9T76XD44IACT
PEPPERMINT OILAV092KU4JHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
GLYCERINPDC6A3C0OXIACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
LAVENDER OILZBP1YXW0H8IACT
WILLOW BARKS883J9JDYXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT

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
Alba Natural Acnedote AstringentSALICYLIC ACIDThe Hain Celestial Group, Inc.939f90e7-e1de-4ca3-a484-90f1b87797d62024-07-31WarningsExact identifier
ndc (package): 61995-2753-6
ndc (product): 61995-2753
ndc11 (package): 61995275306
spl id: 1e916b46-fa34-b7ba-e063-6294a90a9b2f
spl set id: 939f90e7-e1de-4ca3-a484-90f1b87797d6

Reported adverse events (FAERS/openFDA)#

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