FDA.reportPublic FDA data

Bubble Knock Out Acne Spot Treatment

Manufacturer
BUBBLE BEAUTY
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:02

Label at a glance#

ProductBubble Knock Out Acne Spot Treatment
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne Helps clear acne blemishes, acne pimples, blackheads, and whiteheads and allows skin to heal.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.8%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps clear acne blemishes, acne pimples, blackheads, and whiteheads and allows skin to heal.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

skin irritation or dryness may occur, especiallly if used with other topical acne medication. If it occurs, use only one acne treatment at a time, and reduce usage to every other day.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

OTHER SAFETY INFORMATION

  • Avoid storing at extreme temperatures (Below 40F and above 100F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), PENTYLENE GLYCOL, SODIUM POLYACRYLATE, POLYACRYLATE CROSSPOLYMER-6, GAULTHERIA PROCUMBENS (WINTERGREEN) LEAF EXTRACT, GLYCERIN, AZELAIC ACID, SALIX NIGRA (WILLOW) BARK EXTRACT, ALOE BARBADENSIS LEAF JUICE, ZINC PCA, DIPOTASSIUM GLYCYRRHIZATE, SAMBUCUS NIGRA FRUIT JUICE, SPIRAEA ULMARIA FLOWER EXTRACT, CITRIC ACID, SODIUM HYDROXIDE, PHENOXYETHANOL

Questions or comments?

OTC - QUESTIONS SECTION

Call +1 (651) 504-2243

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416909salicylic acid 1.8 % Topical CreamPSN1
416909salicylic acid 18 MG/ML Topical CreamSCD1
416909salicylic acid 1.8 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83509-002-01Bubble Knock Out Acne Spot Treatment1 in 1 CARTONEMULSION11
83509-002-01Bubble Knock Out Acne Spot Treatment10 mL in 1 TUBEEMULSION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83509-002BUBBLE KNOCK OUT ACNE SPOT TREATMENT (SALICYLIC ACID) EMULSION [BUBBLE BEAUTY]1Current NDC, 2 package rows20240507_17cf44cf-55f1-86a5-e063-6294a90a35d2.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83509-00283509-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTYLENE GLYCOL50C1307PZGIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
SALIX NIGRA BARKQU52J3A5B3IACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
AZELAIC ACIDF2VW3D43YTIACT
SALICYLIC ACIDO414PZ4LPZACTIB
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
ALOE VERA LEAFZY81Z83H0XIACT
ZINC PIDOLATEC32PQ86DH4IACT
EUROPEAN ELDERBERRY JUICEZ4IFJ0AK1EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT

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
Bubble Knock Out Acne Spot TreatmentSALICYLIC ACIDBUBBLE BEAUTY17cf44cf-55f1-86a5-e063-6294a90a35d22024-05-06WarningsExact identifier
ndc (package): 83509-002-01
ndc (product): 83509-002
ndc11 (package): 83509000201
spl id: 17cf4f74-9eb0-d2b6-e063-6394a90a6f32
spl set id: 17cf44cf-55f1-86a5-e063-6294a90a35d2

Reported adverse events (FAERS/openFDA)#

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