FDA.reportPublic FDA data

Derm Acne Solution Gel

Manufacturer
Yantai Aien Biotechnology Co., Ltd.
Effective date
2026-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:56

Label at a glance#

ProductDerm Acne Solution Gel
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purpose
Salicylic Acid(0.5%)..Acne treatment

OTC - PURPOSE SECTION

Uses
For the treatment of acne

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenIf swallowed, get medical help orcontact a Poison Control Centerright away.

WARNINGS SECTION

WarningsFor external use only
When using this productSkin 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 acneat a time.
Avoid contact with eyes. If
contact occurs, flush thoroughly
with water.

DOSAGE & ADMINISTRATION SECTION

Cover the entire affected areawith a thin layer one to threetimes daily. Because excessivedrying of the skin may occur, ifneeded or as directed by a doctor.Start with one application daily,then gradually increase to two orthree times daily if needed or asdirected by a doctor.If bothersome dryness of peelingoccurs, reduce application to onea day or every other day.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Acid, Propylene Glycol,
Polyhexanide, Riboflavin, Hyaluronic
Dimethicone, 3-O-Ethyl Ascorbic
Acid, Allantoin, Marine Collagen,
Carbomer Homopolymer, Trolamine,
Water

INDICATIONS & USAGE SECTION

Directions
Cleanse the skin thoroughlybefore applying this product.Cover the entire affected areawith a thin layer one to threetimes daily. Because excessivedrying of the skin may occur, ifneeded or as directed by a doctor.Start with one application daily,then gradually increase to two orthree times daily if needed or asdirected by a doctor.If bothersome dryness of peeling
occurs, reduce application to one
a day or every other day.

87512-003-01 Derm Acne Solution Gel 10g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-003-0187512-003-01

87512-003-02 Derm Acne Solution Gel 15g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-003-287512-003-2

87512-003-03 Derm Acne Solution Gel 20g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-003-0387512-003-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN1
252296salicylic acid 0.005 MG/MG Topical GelSCD1
252296salicylic acid 0.5 % Topical GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87512-003-01Derm Acne Solution Gel10 g in 1 TUBEGEL101
87512-003-02Derm Acne Solution Gel15 g in 1 TUBEGEL151
87512-003-03Derm Acne Solution Gel20 g in 1 TUBEGEL201

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87512-00387512-003-01, 87512-003-02, 87512-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
RIBOFLAVINTLM2976OFRIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
MARINE COLLAGEN, SOLUBLE8JC99XGU4WIACT
3-O-ETHYL ASCORBIC ACID6MW60CB71PIACT
ALLANTOIN344S277G0ZIACT
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLIHEXANIDE322U039GMFIACT
WATER059QF0KO0RIACT

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
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
ndc (package): 87512-003-02
ndc (package): 87512-003-03
ndc (package): 87512-003-01
ndc (product): 87512-003
ndc11 (package): 87512000302
ndc11 (package): 87512000301
ndc11 (package): 87512000303
spl id: 4d6c98ab-801e-63bc-e063-6294a90a20c3
spl set id: 4d6c98ab-801d-63bc-e063-6294a90a20c3

Reported adverse events (FAERS/openFDA)#

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