FDA.reportPublic FDA data

THE INKEY LIST SUCCINIC ACID ACNE TREATMENT

Manufacturer
Brand Evangelists for Beauty Ltd
Effective date
2024-02-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:00

Label at a glance#

ProductTHE INKEY LIST SUCCINIC ACID ACNE TREATMENT
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 1%

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, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Stearic Acid, Cetearyl Alcohol, Colloidal Sulfur, Glycerin, Succinic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Benzyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Ethylhexylglycerin, Sodium Hydroxide, Dehydroacetic Acid, Malachite Extract, Sorbitan Isostearate, Trisodium Ethylenediamine Disuccinate, CI 75810 (Chlorophyllin-Copper Complex).

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free (833) 981-2335

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417424salicylic acid 1 % Topical CreamPSN4
417424salicylic acid 10 MG/ML Topical CreamSCD4
417424salicylic acid 1 % Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81136-017-01THE INKEY LIST SUCCINIC ACID ACNE TREATMENT15 mL in 1 TUBECREAM154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81136-017THE INKEY LIST SUCCINIC ACID ACNE TREATMENT (SALICYLIC ACID) CREAM [BRAND EVANGELISTS FOR BEAUTY LTD]4Legacy NDC, 1 package rows20240228_b4c95bdd-fa10-c024-e053-2a95a90a9e75.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81136-01781136-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
STEARIC ACID4ELV7Z65APIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SULFUR70FD1KFU70IACT
GLYCERINPDC6A3C0OXIACT
SUCCINIC ACIDAB6MNQ6J6LIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SQUALANEGW89575KF9IACT
BENZYL ALCOHOLLKG8494WBHIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POLYSORBATE 60CAL22UVI4MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
DEHYDROACETIC ACID2KAG279R6RIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
SODIUM COPPER CHLOROPHYLLIN1D276TYV9OIACT
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 SUCCINIC ACID ACNE TREATMENTSALICYLIC ACIDBrand Evangelists for Beauty Ltdb4c95bdd-fa10-c024-e053-2a95a90a9e752024-02-26WarningsExact identifier
ndc (package): 81136-017-01
ndc (product): 81136-017
ndc11 (package): 81136001701
spl id: 12510f10-e6d4-2232-e063-6294a90a65d5
spl set id: b4c95bdd-fa10-c024-e053-2a95a90a9e75

Reported adverse events (FAERS/openFDA)#

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