FDA.reportPublic FDA data

ACNE AND BLEMISH CONTROL MASK

Manufacturer
USRX LLC | Packaging On Demand, Inc.
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:22:32

Label at a glance#

ProductACNE AND BLEMISH CONTROL MASK
Active ingredientSULFUR
Label structure7 sections

Indications and uses

For the treatment of acne

Dosage and administration

Clean the skin thoroguhly before applying this product. Cover the entire affected area with a thin layer. Leave on for 10-15 minutes. Rinse skin with warm water. Use 1-2 times a week. Can be applied on pimple as a spot treatment.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses:

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irriation occurs, only use one topical acne medication at a time. Avoid contact with eyes. Apply only to areas with acne. Do not use on broken skin or large areas of the skin.

Stop an dask a doctor

OTC - STOP USE SECTION

if rash or irritation develops and lasts.

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

Clean the skin thoroguhly before applying this product. Cover the entire affected area with a thin layer. Leave on for 10-15 minutes. Rinse skin with warm water. Use 1-2 times a week. Can be applied on pimple as a spot treatment.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

WATER, KAOLIN, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, NIACINAMIDE, GUM ARABIC, CETYL ALCOHOL, BENTONITE, CETEARYL ALCOHOL, CETEARETH-20, BUTYROSPERMUM PARKII (SHEA) BUTTER, SALICYCLIC ACID, HYDROLYZED ARDENIA FLORIDA EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, EUCALYPTUS GLOBULUS LEAF OIL, SALIX NIGRA (WILLOW) BARK EXTRACT, TANACETUM ANNUUM, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, ALPHA-ARBUTIN, KOJIC ACID, AZELAIC ACID, RETINYL PALMITATE, TOCOPHEROL OIL, VACCINIUM MACOCARPON (CRANBERRY) FRUIT EXTRACT, XANTHAN GUM, MALTODEXTRIN, SODIUM PCA, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, GLUTATHIONE, TARTARIC ACID, CITRIC ACID, PHENOXYETHANOL, ETHYLHEXAYLGLYCERIN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AcneMaskAcneMask

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291231sulfur 5 % Medicated Liquid SoapPSN5
1291231sulfur 50 MG/ML Medicated Liquid SoapSCD5
1291231sulfur 5 % Treatment MaskSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70809-1906-1ACNE AND BLEMISH CONTROL MASK1 in 1 BOXCREAM15
70809-1906-1ACNE AND BLEMISH CONTROL MASK73.93 mL in 1 TUBECREAM73.935

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70809-1906ACNE AND BLEMISH CONTROL MASK (SULFER) CREAM [USRX LLC]5Legacy NDC, 2 package rows20241004_a45c4f71-223b-169a-e053-2995a90acc86.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70809-190670809-1906-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
SALICYLIC ACIDO414PZ4LPZIACT
CETYL ALCOHOL936JST6JCNIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GARDENIA JASMINOIDES WHOLE0PK353KHF0IACT
ACACIA5C5403N26OIACT
BENTONITEA3N5ZCN45CIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CRANBERRY JUICEY74M3X3345IACT
SODIUM PIDOLATE1V74VH163TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PEPPERMINT OILAV092KU4JHIACT
AZELAIC ACIDF2VW3D43YTIACT
MALTODEXTRIN7CVR7L4A2DIACT
TARTARIC ACIDW4888I119HIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUTATHIONEGAN16C9B8OIACT
NIACINAMIDE25X51I8RD4IACT
MENTHA PIPERITA79M2M2UDA9IACT
SALIX NIGRA BARKQU52J3A5B3IACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
TANSY OIL43J2812KE1IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
KAOLIN24H4NWX5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALPHA-ARBUTIN72VUP07IT5IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
XANTHAN GUMTTV12P4NEEIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
KOJIC ACID6K23F1TT52IACT

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
236fe910-575e-8ef3-e063-6394a90a222ea45c4f71-223b-169a-e053-2995a90acc862024-10-01WarningsExact identifier
spl id: 236fe910-575e-8ef3-e063-6394a90a222e
spl set id: a45c4f71-223b-169a-e053-2995a90acc86

Reported adverse events (FAERS/openFDA)#

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