FDA.reportPublic FDA data

Spot Stopper Acne Spot Treatment

Manufacturer
The Honest Company, Inc
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:01

Label at a glance#

ProductSpot Stopper Acne Spot Treatment
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredientSalicylic Acid 2%

OTC - PURPOSE SECTION

PurposeAcne treatment

INDICATIONS & USAGE SECTION

Use♦ For the treatment of acne.

WARNINGS SECTION

Warnings

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.

♦ avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

♦ 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 or 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.

SPL UNCLASSIFIED SECTION

Other information

Store in dry, cool conditions.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water (Aqua/Eau), Propanediol, Hamamelis Virginiana (Witch Hazel) Water, Sodium Citrate, Glycolic Acid, Isopentyldiol, Alcohol, Silica, Hydroxyaceto-phenone, Allantoin, Sodium Hydroxide, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Trisodium Ethylenediamine Disuccinate, Chlorella Vulgaris Extract, Lactic Acid, Citric Acid.

SPL UNCLASSIFIED SECTION

HOW TO USE ME

Gently tap a pea-sized amount onto active blemishes and let me dry. If using in the AM, feel free to apply makeup on top.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HONEST ®

SPOT STOPPER ACNE SPOT TREATMENT

NIX THE SPOT

Wintergreen Derived Salicylic Acid + Witch Hazel

0.5 fl. oz. / 15 mL

HONEST.COM

or call 888-862-8818

©2022 Dist. by

The Honest Company, Inc.

Los Angeles, CA 90094

Made in USA from US and imported materials

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN2
346298salicylic acid 0.02 MG/MG Topical GelSCD2
346298salicylic acid 2 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-412-322023-12-19C16284748780-10191ceaa-621d-198a-e063-dbdaa90aec3eSpot Stopper Acne Spot Treatment
69366-412-322023-07-28C16284748780-10191ceaa-621d-198a-e063-dbdaa90aec3eSpot Stopper Acne Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69366-412-32Spot Stopper Acne Spot Treatment1 in 1 CARTONGEL12
69366-412-32Spot Stopper Acne Spot Treatment15 mL in 1 TUBEGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69366-412SPOT STOPPER ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [THE HONEST COMPANY, INC]2Current NDC, Legacy NDC, 2 package rows20231220_dc7afebd-e212-b9ff-e053-2a95a90a15a5.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69366-41269366-412-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCOLIC ACID0WT12SX38SIACT
ISOPENTYLDIOL19NOL5474QIACT
ALCOHOL3K9958V90MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ALLANTOIN344S277G0ZIACT
SODIUM HYDROXIDE55X04QC32IIACT
XANTHAN GUMTTV12P4NEEIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CHLORELLA VULGARISRYQ4R60M02IACT
LACTIC ACID33X04XA5ATIACT
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
Spot Stopper Acne Spot TreatmentSALICYLIC ACIDThe Honest Company, Incdc7afebd-e212-b9ff-e053-2a95a90a15a52023-12-19WarningsExact identifier
ndc (package): 69366-412-32
ndc (product): 69366-412
ndc11 (package): 69366041232
spl id: 0ce46087-f196-a862-e063-6294a90aa421
spl set id: dc7afebd-e212-b9ff-e053-2a95a90a15a5

Reported adverse events (FAERS/openFDA)#

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