FDA.reportPublic FDA data

AcneDote Oil Control Lotion

Manufacturer
The Hain Celestial Group, Inc. | Hain-Celestial Canada, ULC
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:39:46

Label at a glance#

ProductAlba Botanica Acnedote Oil Control
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

Salicylic Acid 2.0%

INDICATIONS & USAGE SECTION

USE

  • For the treatment of acne
  • Apply to freshly cleansed face morning and evening
  • For the best results, use after Alba Botanica Natural ACNEdote Deep Clean Astringent

WARNINGS SECTION

WARNINGS

For external use only.

Avoid direct contact with eyes. If contact occurs, flush thoroughly with water.

OTC - PURPOSE SECTION

Acne Treatment

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

water, Ethylhexyl Stearate,Cetearyl Alcohol, Glycerin, Cetyl Alcohol, Dimethicone, Cetearyl Olivate, Sorbitan Olivate, Polysorbate 60, Azadirachta Indica Leaf Extract (1), Camellia Sinensis Leaf Extract (1), Carum Petroselinum (Parsley) Extract, Melissa Officinalis Leaf Extract, Salix Alba (Willow) Bark Extract, Urtica Dioica (Nettle) Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil (2), Citrus Aurantium Dulcis (Orange) Peel Oil (2), Mentha Piperita (Peppermint) Oil (2), Potassium Hydroxide, Xanthan Gum, Alcohol (1), Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol.

(1) Certified Organic Ingredient; ((2) For scent only

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AL00762 LabelAL00762 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103568salicylic acid 2 % Topical LotionPSN7
103568salicylic acid 20 MG/ML Topical LotionSCD7
103568salicylic acid 2 % Topical LotionSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2062-22025-07-29C16284748780-1ba0f9c33-2821-a910-e053-dadaa90a0b85AcneDote Oil Control Lotion
61995-2062-22021-02-05C16284748780-1ba0f9c33-2821-a910-e053-dadaa90a0b85AcneDote Oil Control Lotion
61995-2062-22021-01-29C16284748780-1ba0f9c33-2821-a910-e053-dadaa90a0b85AcneDote Oil Control Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2062-2Alba Botanica Acnedote Oil Control57 g in 1 TUBELOTION577
61995-2062-2Alba Botanica Acnedote Oil Control1 in 1 CARTONLOTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2062ALBA BOTANICA ACNEDOTE OIL CONTROL (SALICYLIC ACID) LOTION [THE HAIN CELESTIAL GROUP, INC.]7Legacy NDC, 2 package rows20241130_667715e3-b0b0-f6eb-e053-2a91aa0a29ef.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-206261995-2062-2

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
ORANGE OILAKN3KSD11BIACT
BERGAMOT OIL39W1PKE3JIIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
WILLOW BARKS883J9JDYXIACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PARSLEY58FMD0Q0EVIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN OLIVATEMDL271E3GRIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ALCOHOL3K9958V90MIACT
BENZOIC ACID8SKN0B0MIMIACT
DEHYDROACETIC ACID2KAG279R6RIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
SALICYLIC ACIDO414PZ4LPZACTIB
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL OLIVATE58B69Q84JOIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEPPERMINT OILAV092KU4JHIACT

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
2801b3c6-d973-9e86-e063-6394a90ad384667715e3-b0b0-f6eb-e053-2a91aa0a29ef2024-11-28WarningsExact identifier
spl id: 2801b3c6-d973-9e86-e063-6394a90ad384
spl set id: 667715e3-b0b0-f6eb-e053-2a91aa0a29ef

Reported adverse events (FAERS/openFDA)#

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