Concealing Spot Treatment

Manufacturer
Dermalogica, Inc. | PakLab | Diamond Wipes
Effective date
2015-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:08

Label at a glance#

ProductConcealing Spot Treatment
Active ingredientSULFUR
Label structure9 sections

Dosage and administration

Dot onto finger and apply to cleansed skin. Let stand for five seconds, then pat until blended in. Use 1-2 times daily until breakout has cleared.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur (5.0%)

Purpose

OTC - PURPOSE SECTION

Acne treatment

Indications

INDICATIONS & USAGE SECTION

  • For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on broken skin.
  • on large areas of the body.

OTC - WHEN USING SECTION

Using other topical acne medications

  • at the same time or immediately following use of this product may increase dryness or or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if excessive skin irritation develops or increases.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dot onto finger and apply to cleansed skin.
  • Let stand for five seconds, then pat until blended in.
  • Use 1-2 times daily until breakout has cleared.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hamamelis Virginiana (Witch Hazel) Water, Ethyl Trisiloxane, Butylene Glycol, Silica Dimethyl Silylate, Cetearyl Alcohol, Peg-40 Hydrogenated Castor Oil, Dimethicone, Ceratonia Siliqua (Carob) Seed Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Cinnamomum Zeylanicum Bark Extract, Niacinamide, Yeast Extract, Salicylic Acid, Biotin, Zinc Gluconate, Panthenol, Montmorillonite, Caffeine, Lauryl PEG/PPG-18/18 Methicone, Camphor, Capryloyl Glycine, Sarcosine, Ammonium Glycyrrhizate, Ceteareth-20, Potassium Alum, Water, Xanthan Gum, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), (CI 77491), (CI 77499), Titanium Dioxide (CI 77891), Zinc Oxide (CI 77947).

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

new
improved
formula

concealing
spot
treatment

acne treatment

mediBac clearing®

0.33 US FL OZ
10 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
422938sulfur 5 % Topical LotionPSN2
422938sulfur 50 MG/ML Topical LotionSCD2
422938sulfur 5 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-005-002020-01-31C16284748780-19d75b9d1-0384-f424-e053-dadaa90a57ceConcealing Spot Treatment
68479-005-012020-01-31C16284748780-19d75b9d1-0384-f424-e053-dadaa90a57ceConcealing Spot Treatment
68479-005-022020-01-31C16284748780-19d75b9d1-0384-f424-e053-dadaa90a57ceConcealing Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-005-00Concealing Spot Treatment2 mL in 1 POUCHLOTION22
68479-005-01Concealing Spot Treatment3 mL in 1 TUBELOTION32
68479-005-02Concealing Spot Treatment1 in 1 CARTONLOTION12
68479-005-02Concealing Spot Treatment10 mL in 1 TUBELOTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-005CONCEALING SPOT TREATMENT (SULFUR) LOTION [DERMALOGICA, INC.]2Legacy NDC, 4 package rows20151121_556fc017-bf95-4ec0-8c1e-ed646c88ef2c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU702
SULFURACTIVE MOIETY70FD1KFU702
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26C2
BIOTININACTIVE INGREDIENT6SO6U10H042
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CAFFEINEINACTIVE INGREDIENT3G6A5W338E2
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET2
CAPRYLOYL GLYCINEINACTIVE INGREDIENT8TY5YO42NJ2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S2
CINNAMON BARK OILINACTIVE INGREDIENTXE54U569EC2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
ETHYL TRISILOXANEINACTIVE INGREDIENTZH1WJO54812
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
HAMAMELIS VIRGINIANA TOP WATERINACTIVE INGREDIENTNT00Y05A2V2
HORSE CHESTNUTINACTIVE INGREDIENT3C18L6RJAZ2
LAURYL PEG/PPG-18/18 METHICONEINACTIVE INGREDIENTZJ5S27D9NX2
MONTMORILLONITEINACTIVE INGREDIENTA585MN1H2L2
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD42
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY2
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8F2
POTASSIUM ALUMINACTIVE INGREDIENT1L24V9R23S2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ2
SARCOSINEINACTIVE INGREDIENTZ711V88R5F2
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2
YEAST, UNSPECIFIEDINACTIVE INGREDIENT3NY3SM6B8U2
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1Z2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z2

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-00568479-005-02, 68479-005-01, 68479-005-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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 3 · 177 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338ESPRAY, METERED / NASAL10 mg/1mlExact identifier — unii candidate
3 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / OPHTHALMIC2 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii candidate
29 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
2 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
2 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4GEL / TOPICAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION / OPHTHALMIC3 mgExact identifier — unii candidate
9 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338EGRANULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WCAPSULE / ORAL0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION / ORAL3240 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FSOLUTION / DENTAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FCREAM / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WSUSPENSION / ORAL120 mgExact identifier — unii candidate
7 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OILPOLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FTABLET, EXTENDED RELEASE / ORAL50 mgExact identifier — unii candidate
9 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYSPRAY / TOPICAL2.42 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 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
e07cdb00-e54a-411e-9e9d-5e747f9ffc14556fc017-bf95-4ec0-8c1e-ed646c88ef2c2015-11-19WarningsExact identifier
spl id: e07cdb00-e54a-411e-9e9d-5e747f9ffc14
spl set id: 556fc017-bf95-4ec0-8c1e-ed646c88ef2c

Reported adverse events (FAERS/openFDA)#

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