FDA.reportPublic FDA data

Acne LotionSulfur

Manufacturer
Allure Labs Inc
Effective date
2018-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:22

Label at a glance#

ProductAcne LotionSulfur Sulfur
Active ingredientSulfur
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Sulfur 3%

OTC - PURPOSE SECTION

Purpose: Acne Treatment

INDICATIONS & USAGE SECTION

Uses: For the treatment of acne

WARNINGS SECTION

Warning:

  • For external use only
  • Avoid contact with eyes, if product get into eyes, rinse thoroughly with water.
  • If excessive irritation develops or increases discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • After cleansing and toning apply lotion over the entire face.
  • Use daily.
  • If going outside use a sunscreen.
  • Allow Clearogen to dry then follow directions in the sunscreen labeling.
  • If irritation or sensitivity develops, discontinue use of all products and consult a doctor.

INACTIVE INGREDIENT SECTION

Aqua, Lenolenic Acid, Lenoleic Acid, Glycerine, Soybeen, PEG-6 Caprylic/Capric glycerides, Cetostearyl  acohol, Dihexadecyl phosphate, Ceteth-10 phosphate, Dimethicone, Dodecyl gallate, Ethylhexyl gallate, Saw palmetto, Glyceryl monostearate, PEG-100 stearate, Cetyl alcohol, Polyacrylamide, C13- 14 Isoparaffin, Laureth-7, Aloe vera leaf, Phenoxyethanol, Calrylyl Glycol, Ethylhexyl glycerin, Hexylene glycol, Stearic acid, Propylene glycol, Comfrey leaf, Plantago ovata seed, Glutamine, Proline, Leucine, Serine, Trolamine, Green tea leaf, Azadirachta indica leaf, Chamomile, Levender oil, Xantham gum, Alpha-tocopherol acetate, Malva sylvestris extract, Melissa officinalis leaf, Achillea Millefolium, Sodium hyaluronate, Imperata Cylendrica root, Edetate disodium, Magnesium aluminum silicate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advanced Skin & Hair

Los Angeles, California 90025

877-30-CLEAR

clearogen.com

Made In USA

ImageACLS18.jpgImageACLS18.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245607sulfur 3 % Topical LotionPSN1
245607sulfur 30 MG/ML Topical LotionSCD1
245607sulfur 3 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73df98bc-429f-4587-8299-6ad8d52a4f36Product name220250304
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
64b87b8d-6ae7-cef1-8fd2-34228b0cc1bcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4169-1Acne LotionSulfur Sulfur55 mL in 1 BOTTLE, PUMPLOTION551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4169ACNE LOTIONSULFUR SULFUR (SULFUR) LOTION [ALLURE LABS INC]1Current NDC, Legacy NDC, 1 package rows20181127_487d2e65-7fb0-4eee-a082-6b2c192eaf27.zip

Products#

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

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-416962742-4169-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sulfur70FD1KFU70ACTIB
WATER059QF0KO0RIACT
LINOLENIC ACID0RBV727H71IACT
LINOLEIC ACID9KJL21T0QJIACT
GLYCERINPDC6A3C0OXIACT
SOYBEANL7HT8F1ZODIACT
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESGO50W2HWO8IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
DIMETHICONE92RU3N3Y1OIACT
DODECYL GALLATE45612DY463IACT
ETHYLHEXYL GALLATEO14R793D1HIACT
SAW PALMETTOJ7WWH9M8QSIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
ALOE VERA LEAFZY81Z83H0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
STEARIC ACID4ELV7Z65APIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COMFREY LEAFDG4F8T839XIACT
PLANTAGO OVATA SEEDUD50RBY30FIACT
GLUTAMINE0RH81L854JIACT
PROLINE9DLQ4CIU6VIACT
LEUCINEGMW67QNF9CIACT
SERINE452VLY9402IACT
TROLAMINE9O3K93S3TKIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
CHAMOMILEFGL3685T2XIACT
LAVENDER OILZBP1YXW0H8IACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
Acne LotionSulfur SulfurSULFURAllure Labs Inc487d2e65-7fb0-4eee-a082-6b2c192eaf272018-11-09WarningsExact identifier
ndc (package): 62742-4169-1
ndc (product): 62742-4169
ndc11 (package): 62742416901
spl id: b392c601-8a30-414a-a63c-517c08537e0a
spl set id: 487d2e65-7fb0-4eee-a082-6b2c192eaf27

Reported adverse events (FAERS/openFDA)#

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