FDA.reportPublic FDA data

LEROSETT High-Content Organic Acne Treatment

Manufacturer
Cosmetic Specialty labs, Inc.
Effective date
2013-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:26

Label at a glance#

ProductLEROSETT High-Content Organic Acne Treatment Botanically Based
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

for treatment of acne

Dosage and administration

Use twice a day. Wet face, apply to hands, add water and work: into a lather. Massage into your face, rinse.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

PURPOSE

OTC - PURPOSE SECTION

Acne Treatment

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.

USES

INDICATIONS & USAGE SECTION

for treatment of acne

WARNINGS

WARNINGS SECTION

for external use only

SPL UNCLASSIFIED SECTION

Ask a doctor if you are using other topical acne medications at the same time or immediately following use of this product. If increased dryness or irrritation occurs, only one medication should be used, unless directed by a doctor.

SPL UNCLASSIFIED SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use twice a day. Wet face, apply to hands, add water and work: into a lather. Massage into your face, rinse.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf, Caprylyl GIycol, Cocamidopropyl Betaine, Coco-Glucoside, Fragrance, Glyceryl Oleate, Lauramide DEA, Lauryl Glucoside, Phenoxyethanol, Purified Water, Sodium Citrate, Sodium Lauryl Glucose Carboxylate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display Panel
Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1423838LEROSETT 2 % Medicated Liquid SoapPSN1
562600salicylic acid 2 % Medicated Liquid SoapPSN1
1423838salicylic acid 20 MG/ML Medicated Liquid Soap [LEROSETT]SBD1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
1423838LEROSETT 2 % Medicated Liquid SoapSY1
1423838LEROSETT 20 MG/ML Medicated Liquid SoapSY1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-062-132020-01-31C16284748780-19d75b9d0-2fa1-f424-e053-dadaa90a57ce10e91140-652c-4275-8f38-dedd29786e8e
58133-062-672020-01-31C16284748780-19d75b9d0-2fa1-f424-e053-dadaa90a57ce10e91140-652c-4275-8f38-dedd29786e8e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-062-13LEROSETT High-Content Organic Acne TreatmentBotanically Based385 mL in 1 BOTTLEGEL3851
58133-062-67LEROSETT High-Content Organic Acne TreatmentBotanically Based200 mL in 1 BOTTLEGEL2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-062LEROSETT HIGH-CONTENT ORGANIC ACNE TREATMENT BOTANICALLY BASED (SALICYLIC ACID) GEL [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 2 package rows20130515_10e91140-652c-4275-8f38-dedd29786e8e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225B1
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79P1
LAURIC DIETHANOLAMIDEINACTIVE INGREDIENTI29I2VHG381
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCU1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
SODIUM LAURYL GLYCOL CARBOXYLATEINACTIVE INGREDIENT8L0472VMYL1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-06258133-062-67, 58133-062-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO GLUCOSIDEICS790225BIACT
GLYCERYL OLEATE4PC054V79PIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL GLYCOL CARBOXYLATE8L0472VMYLIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PCREAM, AUGMENTED / TOPICAL3.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38EMULSION / TOPICAL15 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PFILM, EXTENDED RELEASE / TRANSDERMAL18.8 mgExact identifier — unii candidate
7 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38LOTION / TOPICAL0.6 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PCAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38SHAMPOO, SUSPENSION / TOPICAL4 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38SUSPENSION / TOPICAL0.48 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PTABLET / ORAL3 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PSPRAY / TOPICAL0.95 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38SPONGE / TOPICAL5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERYL OLEATEGLYCERYL OLEATE4PC054V79PGEL / TOPICAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
LAURIC DIETHANOLAMIDELAURIC DIETHANOLAMIDEI29I2VHG38SHAMPOO / TOPICAL20 %w/wExact identifier — unii candidate
6 equally ranked IID candidates

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
ff70bbb4-b434-483f-a510-3b811a1b331b10e91140-652c-4275-8f38-dedd29786e8e2013-01-24WarningsExact identifier
spl id: ff70bbb4-b434-483f-a510-3b811a1b331b
spl set id: 10e91140-652c-4275-8f38-dedd29786e8e

Reported adverse events (FAERS/openFDA)#

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