FDA.reportPublic FDA data

RosaAcne Relief

Manufacturer
Kunming Zhongzhou Pharmaceutical Co, Ltd
Effective date
2018-07-30
Label type
HUMAN OTC DRUG LABEL
Version
32463
Source
full-release
Hydrated at
2026-05-31 22:56:29

Label at a glance#

ProductRosaAcne Relief
Active ingredientSULFUR, SALICYLIC ACID
Label structure12 sections

Indications and uses

For the treatment of acne

Dosage and administration

Cleanse the skin thoroughly before applying this product twice a day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sulfur         7.1%
Salicylic Acid           3%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

Warning

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

1. Some patients may have aggravated symptoms within 10 days of use; but may start to improve after 2 weeks.
2. The product is recommended to use continuously without interruption.
3. Skin irritation and dryness are likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne product at a time.
4. Pregnant or breast-feeding women and children use with caution.
5. Avoid contact with eyes.
6. If dryness, slight burn feeling or skin peeling occurs, reduce application and use one time a day or every other day.

Do not use

OTC - DO NOT USE SECTION

If you are allergic to any ingredient(s) of the product.

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

Cleanse the skin thoroughly before applying this product twice a day.

Storage

OTHER SAFETY INFORMATION

Keep in a dry, cool place away from direct sunlight.

Manufactured by:Kunming Zhongzhou Pharmaceutical Co. LtdNo. 16 Jingdong Road, Kunming, ChinaMade in China

SPL UNCLASSIFIED SECTION

Distributed exclusively by:
AL Lauren Corp. Temple City, CA 91780 USA

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Zinc Oxide, Boric Acid, Menthol, Dimethicone, Petrolatum, Stearic Acid, Octadecanol (Mixture of Isomers), Glycerin,
Glyceryl Monostearate, Water

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2050430salicylic acid 3 % / sulfur 7.1 % Topical OintmentPSN32463
2050430salicylic acid 0.03 MG/MG / sulfur 0.071 MG/MG Topical OintmentSCD32463
2050430salicylic acid 3 % / sulfur 7.1 % Topical OintmentSY32463

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72317-001-012022-01-28C16284748780-1d6a99b39-691c-a426-e053-dadaa90af4c2Kunming Zhongzhou Pharmaceutical Co, Ltd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72317-001-01RosaAcne Relief1 in 1 BOXOINTMENT132463
72317-001-01RosaAcne Relief20 g in 1 BOTTLE, PLASTICOINTMENT2032463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72317-001ROSAACNE RELIEF (SULFUR, SALICYLIC ACID) OINTMENT [KUNMING ZHONGZHOU PHARMACEUTICAL CO, LTD]32463Legacy NDC, 2 package rows20180731_2fda4df9-9449-4ded-b903-b93dd8efb19b.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72317-00172317-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
Zinc OxideSOI2LOH54ZIACT
Boric AcidR57ZHV85D4IACT
MentholL7T10EIP3AIACT
Dimethicone92RU3N3Y1OIACT
Petrolatum4T6H12BN9UIACT
Stearic Acid4ELV7Z65APIACT
OCTADECANOL (MIXTURE OF ISOMERS)C6BPY2QY39IACT
GlycerinPDC6A3C0OXIACT
Glyceryl Monostearate230OU9XXE4IACT
WATER059QF0KO0RIACT

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
e9dd15ee-22bd-4bcd-b5ff-20cb9bf8a4af2fda4df9-9449-4ded-b903-b93dd8efb19b2018-07-30WarningsExact identifier
spl id: e9dd15ee-22bd-4bcd-b5ff-20cb9bf8a4af
spl set id: 2fda4df9-9449-4ded-b903-b93dd8efb19b

Reported adverse events (FAERS/openFDA)#

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