FDA.reportPublic FDA data

Clinicians Complex Acne Drying Lotion

Manufacturer
Cosmed Dermaceuticals, Inc. | Southeast Holdings Corp
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:43:16

Label at a glance#

ProductClinicians Complex
Active ingredientSULFUR
Label structure10 sections

Indications and uses

For the treatment of acne • Dries up acne pimples • Dries and clears acne blemishes Helps keep skin clear of new acne blemishes

Dosage and administration

​DO NOT SHAKE SOLUTION ​ • Cleanse the skin thoroughly before applying medication • Dip clean cotton swab into sediment and apply directly to blemishes.  Because excessive drying of the skin may occur, limit use to one application daily, or as directed by a physician.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses:

INDICATIONS & USAGE SECTION

For the treatment of acne • Dries up acne pimples • Dries and clears acne blemishes

Helps keep skin clear of new acne blemishes

Warnings:

WARNINGS SECTION

For external use only • 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 use one topical acne medication at a time • Do not use on broken skin or large areas of the skin • When using this product apply only to areas with acne.  Avoid contact with eyes • If excessive irritation develops or increases, discontinue use and consult a doctor • Keep out of reach of children • If swallowed, get medical help or contact Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

​DO NOT SHAKE SOLUTION​ • Cleanse the skin thoroughly before applying medication • Dip clean cotton swab into sediment and apply directly to blemishes.  Because excessive drying of the skin may occur, limit use to one application daily, or as directed by a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

Other Information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun light.

Questions or Comments:

OTC - QUESTIONS SECTION

Distibuted by: Cosmed Dermaceuticals, Inc.

Atlanta, GA 30517 • www.cosmedderm.com • Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240725sulfur 10 % Topical LotionPSN10
240725sulfur 100 MG/ML Topical LotionSCD10
240725sulfur 10 % Topical LotionSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61352-001-01Clinicians Complex31 g in 1 BOTTLE, GLASSLOTION3110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU702
SULFURACTIVE MOIETY70FD1KFU702
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61352-00161352-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SALICYLIC ACIDO414PZ4LPZIACT
SULFUR70FD1KFU70ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-12-08full-release2026-06-01 00:41:19

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 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
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
ndc (package): 61352-001-01
ndc (product): 61352-001
ndc11 (package): 61352000101
spl id: 4356bf6a-35f0-10f1-e063-6294a90a43ad
spl set id: 256e3e4e-2219-45f8-ab78-a6a541767de8

Reported adverse events (FAERS/openFDA)#

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