FDA.reportPublic FDA data

Anti-Acne Lotion

Manufacturer
PT Galenium Pharmasia Laboratories
Effective date
2020-02-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:03:51

Label at a glance#

ProductJoesoef Skincare Anti Acne
Active ingredientSULFUR
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients                     Purpose

Precipitated Sulfur 6.6%..............Acne medication

OTC - PURPOSE SECTION

Use for the treatment of acne. Penetrades pores to clear most acne blemishes, acne pimples, blackhead, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

In case of incidental ingestion, get medical help or contact a poison control center immediately.

INDICATIONS & USAGE SECTION

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Using a cotton swab, cover the entire effected area with a thin layer one to three times daily.
  • Because excessive drying of the skim may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Shake well before use

WARNINGS SECTION

Warnings

For external use only

DOSAGE & ADMINISTRATION SECTION

When using this product

  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Do not get into eyes. If excessive skin irridation develops or increases, discontinue use and consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Purified water, Ethyl alcohol, DMDM Hydantoin, Cabomer, Fragrance, Triethanolamine, Calcium oxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1547634sulfur 6.6 % Topical LotionPSN4
1547634sulfur 66 MG/ML Topical LotionSCD4
1547634sulfur 6.6 % Topical LotionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
26050-112-012022-01-28C16284748780-19d75b9d0-690d-f424-e053-dadaa90a57ceAnti-Acne Lotion
26050-112-012020-02-25C16284748780-19d75b9d0-690d-f424-e053-dadaa90a57ceAnti-Acne Lotion
26050-112-012020-01-31C16284748780-19d75b9d0-690d-f424-e053-dadaa90a57ceAnti-Acne Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26050-112-01Joesoef Skincare Anti Acne95 mL in 1 BOTTLELOTION954

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26050-112JOESOEF SKINCARE ANTI ACNE (SULFUR) LOTION [PT GALENIUM PHARMASIA LABORATORIES]4Legacy NDC, 1 package rows20200226_be8a5e8c-18c7-4dc8-a19c-99c963700c1d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU702
SULFURACTIVE MOIETY70FD1KFU702
CARBOMER 1342INACTIVE INGREDIENT809Y72KV362
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW2
LIME (CALCIUM OXIDE)INACTIVE INGREDIENTC7X2M0VVNH2
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA74682
TRIETHANOLAMINE BENZOATEINACTIVE INGREDIENTM3EN4GC19W2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
26050-11226050-112-01

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DMDM HYDANTOINBYR0546TOWIACT
CARBOMER 1342809Y72KV36IACT
TRIETHANOLAMINE BENZOATEM3EN4GC19WIACT
LIME (CALCIUM OXIDE)C7X2M0VVNHIACT
SULFUR70FD1KFU70ACTIB

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36FILM, EXTENDED RELEASE / TRANSDERMAL38.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SOLUTION / OPHTHALMIC0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SPRAY / NASAL1 mgExact identifier — unii candidate
9 equally ranked IID candidates
LIME (CALCIUM OXIDE)LIME (CALCIUM OXIDE)C7X2M0VVNHSOLUTION, CONCENTRATE / ORAL0.1 ml/1mlExact identifier — unii candidate
2 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TOPICAL150 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468INHALANT / RESPIRATORY (INHALATION)277.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SUSPENSION / INTRAMUSCULAR5 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SOLUTION / AURICULAR (OTIC)0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36LOTION / TOPICAL29 mgExact identifier — unii candidate
6 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TRANSDERMAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468CREAM / TOPICALNAExact identifier — unii candidate
9 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468CREAM / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
LIME (CALCIUM OXIDE)LIME (CALCIUM OXIDE)C7X2M0VVNHCAPSULE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36CREAM / TOPICAL2 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
9 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii candidate
PHENETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER 1342CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36EMULSION / OPHTHALMIC0.05 %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
9f6861c8-6d8a-4567-e053-2995a90aa25cbe8a5e8c-18c7-4dc8-a19c-99c963700c1d2020-02-25WarningsExact identifier
spl id: 9f6861c8-6d8a-4567-e053-2995a90aa25c
spl set id: be8a5e8c-18c7-4dc8-a19c-99c963700c1d

Reported adverse events (FAERS/openFDA)#

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