FDA.reportPublic FDA data

The INKEY List Beta Hydroxy Acid Serum

Manufacturer
Brand Evangelists for Beauty Ltd | Orean Beauty Inc
Effective date
2024-02-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:01

Label at a glance#

ProductThe INKEY List Beta Hydroxy Acid Serum
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

• for the treatment of acne.

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 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

• for the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If contact occurs, flush thoroughly with water. Avoid contact with eyes. 

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

SPL UNCLASSIFIED SECTION

Avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propanediol, Betaine, Sodium Hyaluronate, Zinc PCA, Phenoxyethanol, Hydroxyethylcellulose, Maltodextrin, Sodium Hydroxide, Ethylhexylglycerin, Biosaccharide Gum-1, Trisodium Ethylenediamine Disuccinate.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free (833) 981-2335

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3Box3Box3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN3
346298salicylic acid 0.02 MG/MG Topical GelSCD3
346298salicylic acid 2 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81136-021-01The INKEY List Beta Hydroxy Acid Serum30 mL in 1 BOTTLEGEL303
81136-021-01The INKEY List Beta Hydroxy Acid Serum1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81136-021THE INKEY LIST BETA HYDROXY ACID SERUM (SALICYLIC ACID) GEL [BRAND EVANGELISTS FOR BEAUTY LTD]3Current NDC, Legacy NDC, 2 package rows20240228_d554920f-e33a-484b-bbd8-513715616384.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81136-02181136-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
BETAINE3SCV180C9WIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ZINC PIDOLATEC32PQ86DH4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM HYDROXIDE55X04QC32IIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
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
The INKEY List Beta Hydroxy Acid SerumSALICYLIC ACIDBrand Evangelists for Beauty Ltdd554920f-e33a-484b-bbd8-5137156163842024-02-26WarningsExact identifier
ndc (package): 81136-021-01
ndc (product): 81136-021
ndc11 (package): 81136002101
spl id: 1250ff1a-90a6-9d47-e063-6394a90ad3ae
spl set id: d554920f-e33a-484b-bbd8-513715616384

Reported adverse events (FAERS/openFDA)#

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