FDA.reportPublic FDA data

Sulfur

Manufacturer
Meixin Beauty & Health Care Products Co., Ltd.
Effective date
2022-04-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:49:03

Label at a glance#

ProductSulfur
Active ingredientSALICYLIC ACID, SULFUR
Label structure12 sections

Dosage and administration

Make lather with sponge. Apply to affected areas. Leave lather on skin for 3 to 5 minutes. Rinse thoroughly with water and gently pat dry with a clean toweI. May be used 1 to 3 times a day or as directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur10.0% ，Salicylic Acid3.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

On broken skin on large areas of the skin

When Using This Product

OTC - WHEN USING SECTION

Apply only to areas with acne.

Do not allow contact with the eyes and mucous membranes.

If undue skin irritation develops or increases , discontinue use and consult a physician.

Skin irritation and dryness are more likely to occur if you use another topical medication at the same time.

If irritation occurs , only use one topical acne medication at a time.

OTC - STOP USE SECTION

If undue skin irritation develops or increases , discontinue use and consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

If swallowed , get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Make lather with sponge.

Apply to affected areas.

Leave lather on skin for 3 to 5 minutes.

Rinse thoroughly with water and gently pat dry with a clean toweI.

May be used 1 to 3 times a day or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium palmitate, Sodium palm kernelate, Water , Glycerin , Tetrasodium EDTA ,Soyethyl morpholinium ethosulfate , Lavender essential oil

Indications

INDICATIONS & USAGE SECTION

For use in the management of acne.

Dries up blackheads and whiteheads.

Penetrates pores to eliminate most acne pimples.

Helps keep skin clear of new acne blemishes

Directions

RECENT MAJOR CHANGES SECTION

Make lather with sponge.

Apply to affected areas.

Leave lather on skin for 3 to 5 minutes.

Rinse thoroughly with water and gently pat dry with a clean toweI.

May be used 1 to 3 times a day or as directed by a doctor

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120g 78565-106-01

78565-106-0178565-106-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2586352salicylic acid 3 % / sulfur 10 % Medicated Liquid SoapPSN5
2586352salicylic acid 30 MG/ML / sulfur 100 MG/ML Medicated Liquid SoapSCD5
2586352salicylic acid 3 % / sulfur 10 % Medicated Liquid SoapSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78565-106-022024-01-30C16284748780-11030e365-2c55-111a-e063-dadaa90a10e278565-106 Sulfur soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78565-106-02Sulfur240 g in 1 BOXSOAP2405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78565-106SULFUR (SULFUR SOAP) SOAP [MEIXIN BEAUTY & HEALTH CARE PRODUCTS CO., LTD.]5Legacy NDC, 1 package rows20220402_d1e8a663-ef04-3014-e053-2a95a90a6382.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78565-10678565-106-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
SOYETHYL MORPHOLINIUM ETHOSULFATEJ8C5W5HH18IACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM PALMITATEJQ43KP6296IACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SULFUR70FD1KFU70ACTIB
GLYCERINPDC6A3C0OXIACT

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
dba88dcb-f3dd-f5af-e053-2995a90a025cd1e8a663-ef04-3014-e053-2a95a90a63822022-04-02WarningsExact identifier
spl id: dba88dcb-f3dd-f5af-e053-2995a90a025c
spl set id: d1e8a663-ef04-3014-e053-2a95a90a6382

Reported adverse events (FAERS/openFDA)#

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