FDA.reportPublic FDA data

Skincoach CLEAN

Manufacturer
SKIN COACH SL. | Topiderm Inc. II
Effective date
2019-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:01

Label at a glance#

ProductSkincoach CLEAN
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

Skin cleanser for the treatment of acne.

Dosage and administration

Wet affected area, apply, and rinse well. • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician • If bothersome dryness occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                          Purpose

Salicylic Acid USP 2%------------ Acne medication

Uses

INDICATIONS & USAGE SECTION

Skin cleanser for the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

Keep away from eyes, lips, and mouth.

Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of childen. If swallowed, get medical help or contact a Poison Control Center.

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.

Directions

OTC - PURPOSE SECTION

Wet affected area, apply, and rinse well. • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician • If bothersome dryness occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate,  Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73047-004-012021-07-23C16284748780-1c7ccaba7-0ea0-fd44-e053-dadaa90aa01b8d5db0d3-d839-415b-9d94-21dcc0a2941b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73047-004-01Skincoach CLEAN200 mL in 1 TUBELIQUID2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73047-004SKINCOACH CLEAN (SALICYLIC ACID) LIQUID [SKIN COACH SL.]1Legacy NDC, 1 package rows20190809_8d5db0d3-d839-415b-9d94-21dcc0a2941b.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73047-00473047-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
GREEN TEA LEAFW2ZU1RY8B0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE DISODIUM7FLD91C86KIACT
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 46000 MW)LQ35R50VR1IACT
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE5Q87K461JOIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM C12-15 PARETH-15 SULFONATE353VA59XH8IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
TROLAMINE9O3K93S3TKIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ZINC PIDOLATEC32PQ86DH4IACT

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
3266a7e1-ed61-4b22-ba00-d8f36fc8e7b48d5db0d3-d839-415b-9d94-21dcc0a2941b2019-08-06WarningsExact identifier
spl id: 3266a7e1-ed61-4b22-ba00-d8f36fc8e7b4
spl set id: 8d5db0d3-d839-415b-9d94-21dcc0a2941b

Reported adverse events (FAERS/openFDA)#

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