FDA.reportPublic FDA data

Skincoach TREAT

Manufacturer
SKIN COACH SL. | Topiderm Inc. II
Effective date
2019-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:42

Label at a glance#

ProductSkincoach TREAT
Active ingredientBENZOYL PEROXIDE
Label structure7 sections

Indications and uses

Topical acne medication.

Dosage and administration

■ Cleanse the skin thoroughly belore applying. ■ Apply a thin layer daily,then gradually increase to two or three times daily. ■ If bothersome drying or peeling occurs, reduce applications. ■ If going outside, use a sunscreen.  If initation or sensitivity develops, discontinue use of both products and consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                               Purpose

Benzoyl Peroxide USP 5%------------ Anti-acne

Uses

INDICATIONS & USAGE SECTION

Topical acne medication.

Warnings

WARNINGS SECTION

When using this product avoid unnecessary sun exposure and use a sunscreen. ■ For external use only ■ Keep away from eyes, lips, and mouth ■ If irritation develops discontinue use and consult a doctor ■ Using other topical acne medications at the same time or immediately,
following use of this product may increase dryness or irritation of the skin. If this occurs consult a doctor. ■May bleach fabrics.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of childen. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

OTC - PURPOSE SECTION

■ Cleanse the skin thoroughly belore applying. ■ Apply a thin layer daily,then gradually increase to two or three times daily. ■ If bothersome drying or peeling occurs, reduce applications. ■ If going outside, use a sunscreen. If initation or sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Purified Water, Sodium hydroxymethylglycinate, Sodium Lauroyl sarcosinate, Stearic Acid.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN1
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD1
308694benzoyl peroxide 5 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73047-003-012021-07-23C16284748780-1c7ccaba7-1284-fd44-e053-dadaa90aa01b0797ae5e-8b81-4ca5-8452-68578c4f8379

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73047-003-01Skincoach TREAT57 g in 1 TUBEGEL571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73047-003SKINCOACH TREAT (BENZOYL PEROXIDE) GEL [SKIN COACH SL.]1Legacy NDC, 1 package rows20190618_0797ae5e-8b81-4ca5-8452-68578c4f8379.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73047-00373047-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
WATER059QF0KO0RIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
STEARIC ACID4ELV7Z65APIACT

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
428691a1-5357-4afa-a7a8-1e9f2b22e43b0797ae5e-8b81-4ca5-8452-68578c4f83792019-05-21WarningsExact identifier
spl id: 428691a1-5357-4afa-a7a8-1e9f2b22e43b
spl set id: 0797ae5e-8b81-4ca5-8452-68578c4f8379

Reported adverse events (FAERS/openFDA)#

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