FDA.reportPublic FDA data

blackhead solutions self-heating blackhead extractor acne medication

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | PALC | Estee Lauder N.V. | The Estee Lauder Inc | Northtec LLC
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:48:44

Label at a glance#

Productblackhead solutions self-heating blackhead extractor acne medication
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

reduces the number of blackheads helps keep skin clear of new blackheads helps prevent development of new blackheads

Dosage and administration

Use 3 times a week on clean, dry skin. Unscrew top to dispense product. Apply thin layer on blackhead-prone areas. Reattach top. Wet product on skin to activate heat. Massage 15-30 seconds with applicator tip, then rinse.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • reduces the number of blackheads
  • helps keep skin clear of new blackheads
  • helps prevent development of new blackheads

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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 one topical acne medication should be used unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of eyes.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use 3 times a week on clean, dry skin.
  • Unscrew top to dispense product.
  • Apply thin layer on blackhead-prone areas.
  • Reattach top.
  • Wet product on skin to activate heat.
  • Massage 15-30 seconds with applicator tip, then rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

magnesium sulfate • dimethicone • isononyl isononanoate • isododecane • polysilicone-11 • phenyl trimethicone • hydrogenated lecithin • acetyl glucosamine • polysorbate 20 • polysorbate 80 • polyethylene • diatomaceous earth\solum diatomeae\terre de diatomées • triethylhexanoin • pumice • bambusa arundinacea (bamboo) stem extract • peg-15/lauryl dimethicone crosspolymer • caprylyl glycol • stearyl glycyrrhetinate • water\aqua\eau • silica [iln43644]

PRINCIPAL DISPLAY PANEL - 20 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

blackheads

CLINIQUE

blackhead

solutions

self-heating

blackhead

extractor

SALICYLIC ACID

ACNE MEDICATION

ALL SKIN TYPES

.68 FL.OZ.LIQ./20 ml e

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417424salicylic acid 1 % Topical CreamPSN8
417424salicylic acid 10 MG/ML Topical CreamSCD8
417424salicylic acid 1 % Topical CreamSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-061-012022-08-04C16284748780-1e4f33bdf-9f7a-d8a0-e053-dadaa90a6e4eblackhead solutions self-heating blackhead extractor acne medication
49527-061-012022-07-29C16284748780-1e4f33bdf-9f7a-d8a0-e053-dadaa90a6e4eblackhead solutions self-heating blackhead extractor acne medication

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-061-01blackhead solutions self-heating blackhead extractor acne medication20 mL in 1 TUBE, WITH APPLICATORCREAM208
49527-061-01blackhead solutions self-heating blackhead extractor acne medication1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-061BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION (SALICYLIC ACID) CREAM [CLINIQUE LABORATORIES LLC]8Legacy NDC, 2 package rows20241226_e36ba6f7-5d75-4a12-af03-2a4b60a712e4.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-06149527-061-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BAMBUSA BAMBOS STEMNRA4497HC5IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHICONE92RU3N3Y1OIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
ISODODECANEA8289P68Y2IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
N-ACETYLGLUCOSAMINEV956696549IACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
PUMICENT5NN5KL16IACT
CAPRYLYL GLYCOL00YIU5438UIACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
2a14cf87-3242-933d-e063-6294a90aff74e36ba6f7-5d75-4a12-af03-2a4b60a712e42024-12-25WarningsExact identifier
spl id: 2a14cf87-3242-933d-e063-6294a90aff74
spl set id: e36ba6f7-5d75-4a12-af03-2a4b60a712e4

Reported adverse events (FAERS/openFDA)#

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