FDA.reportPublic FDA data

ACNE SPOT TREATMENT

Manufacturer
Skinfix, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:32:21

Label at a glance#

ProductACNE SPOT TREATMENT 2% BHA
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

HELPS CLEAR ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

Dosage and administration

APPLY DIRECTLY ONYO BLEMISH OR AFFECTED AREA AFTER CLEANSING 1-2X DAILY. ALLERGY ALERT  DO NOT USE THIS PRODUCT IF YOU HAVE A KNOWN ALLERGY TO SALICYLIC ACID.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID 2%

Purpose

OTC - PURPOSE SECTION

ACNE TREATMENT

USES

INDICATIONS & USAGE SECTION

HELPS CLEAR ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

APPLY DIRECTLY ONYO BLEMISH OR AFFECTED AREA AFTER CLEANSING 1-2X DAILY.

ALLERGY ALERT  DO NOT USE THIS PRODUCT IF YOU HAVE A KNOWN ALLERGY TO SALICYLIC ACID.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (EAU), KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, AZELAIC ACID, PROPANEDIOL, STEARYL ALCOHOL, POLYGLYCERYL-2 STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, BENTONITE, TOCOPHEROL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, GLYCERYL STEARATE, ZINC PCA, STEARYL GLYCYRRHETINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CITRIC ACID, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM BENZOATE

QUESTIONS?

OTC - QUESTIONS SECTION

1.866.927.2783

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61328-404-0561328-404-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN5
317152salicylic acid 20 MG/ML Topical CreamSCD5
317152salicylic acid 2 % Topical CreamSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-404-05ACNE SPOT TREATMENT2% BHA15 mL in 1 TUBECREAM155

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61328-40461328-404-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
AZELAIC ACIDF2VW3D43YTIACT
PROPANEDIOL5965N8W85TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
KAOLIN24H4NWX5COIACT
NIACINAMIDE25X51I8RD4IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCERINPDC6A3C0OXIACT
BENTONITEA3N5ZCN45CIACT
C14-22 ALCOHOLSB1K89384RJIACT
POLYDEXTROSEVH2XOU12IEIACT
ICODEXTRIN2NX48Z0A9GIACT
AMYLOPECTIN, UNSPECIFIED SOURCE4XO4QFV777IACT
COCO GLUCOSIDEICS790225BIACT
ZINC PIDOLATEC32PQ86DH4IACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
COCONUT ALCOHOL13F4MW8Y9KIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-12-29monthly-update2026-06-03 17:46:51

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
ACNE SPOT TREATMENT 2% BHASALICYLIC ACIDSkinfix, Inc.ceccea68-07d8-0903-e053-2995a90ab2b72026-01-12WarningsExact identifier
ndc (package): 61328-404-05
ndc (product): 61328-404
ndc11 (package): 61328040405
spl id: 483368a7-95f2-5d8d-e063-6394a90a232e
spl set id: ceccea68-07d8-0903-e053-2995a90ab2b7

Reported adverse events (FAERS/openFDA)#

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