FDA.reportPublic FDA data

PHOFAY ACNE SPOT TREATMENT Cream

Manufacturer
Longway Technology(Guangzhou) Co., Ltd.
Effective date
2025-08-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:05

Label at a glance#

ProductPHOFAY ACNE SPOT TREATMENT Cream
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID1.08%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf Swallowed, Get Medica Help or Contact a Poison Control Center right away

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. lf irritation occurs, only use one topical acne medication at a time.

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.

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate, Propylene Glycol, Dimethicone Cetearyl Alcohol, C14-22 Alcohols, Glyceryl Stearate，Niacinamide, Betaine,PEG-100 Stearate, 1,2-Hexanediol,Hydroxyacetophenone, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, C12-20 Alkyl Glucoside,Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum,Centella Asiatica Root Extract, Menthol, Dipotassium Glycyrrhizate, Citric Acid, lron Oxides (Cl 77492)

OTHER SAFETY INFORMATION

protect the product in this container from excessive

heat and direct sun

OTC - PURPOSE SECTION

Acne treatment

INDICATIONS & USAGE SECTION

For the treatment of acne
Reduces the number of acne blemishes

Helps prevent the development of new acne pimples

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHOFAY ACNE SPOT TREATMENT CREAMPHOFAY ACNE SPOT TREATMENT CREAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2722593salicylic acid 1.08 % Topical CreamPSN1
2722593salicylic acid 10.8 MG/ML Topical CreamSCD1
2722593salicylic acid 1.08 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85161-132-01PHOFAY ACNE SPOT TREATMENT Cream1 g in 1 BOTTLECREAM11
85161-132-01PHOFAY ACNE SPOT TREATMENT Cream1 in 1 BOXCREAM11

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85161-13285161-132-01

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
GLYCERYL STEARATE230OU9XXE4IACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
CENTELLA ASIATICA ROOT8MXU1P42J0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PEG-100 STEARATEYD01N1999RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
NIACINAMIDE25X51I8RD4IACT
MENTHOLL7T10EIP3AIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
XANTHAN GUMTTV12P4NEEIACT
C14-22 ALCOHOLSB1K89384RJIACT
CITRIC ACID2968PHW8QPIACT
CI 77492EX438O2MRTIACT
SALICYLIC ACIDO414PZ4LPZACTIB
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
DIMETHICONE92RU3N3Y1OIACT
BETAINE3SCV180C9WIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM HYDROXIDE55X04QC32IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT

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
PHOFAY ACNE SPOT TREATMENT CreamSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.3d0511f6-168b-5377-e063-6294a90a3ca92025-08-23WarningsExact identifier
ndc (package): 85161-132-01
ndc (product): 85161-132
ndc11 (package): 85161013201
spl id: 3d0511f6-168c-5377-e063-6294a90a3ca9
spl set id: 3d0511f6-168b-5377-e063-6294a90a3ca9

Reported adverse events (FAERS/openFDA)#

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