FDA.reportPublic FDA data

STOP SPOT

Manufacturer
Clearly Pte Ltd | CHAKS COSMETIC DESIGN & SERVICES PTE LTD
Effective date
2023-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:21

Label at a glance#

ProductSTOP SPOT
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

Clears acne blemishes and allows the skin to heal

Dosage and administration

Clean the skin thoroughly before applying this product cover the entire affected area/spot 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

Label contents#

Full prescribing information#

Active ingredient 

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

Clears acne blemishes and allows the skin to heal

Warnings

WARNINGS SECTION

For External Use Only

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

Keep out of Reach of Children, if ingested, seek medical help or contact Poison
Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product
  • cover the entire affected area/spot 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

Other information

INACTIVE INGREDIENT SECTION

Store below 30°C (86° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat, glycerin, butylene glycol, propanediol, PEG-30 castor oil, dipotassium glycyrrhizate, phenoxyethanol, glycolic acid, sclerotium gum,xanthum gum, sodium hydroxide, farnesol, ethylhexylglycerin, sulfur

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72521-001-012025-01-30C16284748780-12cef2736-909d-d83d-e063-dadaa90ab31fa0ede9a8-ff34-4c00-a6ca-f227d0df17a7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72521-001-01STOP SPOT15 mL in 1 TUBEGEL152
72521-001-01STOP SPOT1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72521-001STOP SPOT (SALICYLIC ACID) GEL [CLEARLY PTE LTD]2Legacy NDC, 2 package rows20230120_a0ede9a8-ff34-4c00-a6ca-f227d0df17a7.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72521-00172521-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPANEDIOL5965N8W85TIACT
PEG-30 CASTOR OILGF873K38RZIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCOLIC ACID0WT12SX38SIACT
BETASIZOFIRAN2X51AD1X3TIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
FARNESOLEB41QIU6JLIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SULFUR70FD1KFU70IACT
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
f2258c7d-4acd-2570-e053-2995a90a76f2a0ede9a8-ff34-4c00-a6ca-f227d0df17a72023-01-13WarningsExact identifier
spl id: f2258c7d-4acd-2570-e053-2995a90a76f2
spl set id: a0ede9a8-ff34-4c00-a6ca-f227d0df17a7

Reported adverse events (FAERS/openFDA)#

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