FDA.reportPublic FDA data

XtraCare Deep Cleaning Astringent

Manufacturer
Rejoice International | China Ningbo Shangge Cosmetic Technology Corp
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:05

Label at a glance#

ProductXtraCare Deep Cleaning Astringent
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                          Purpose

Salicylic Acid 2% ................ Acne Medication

OTC - PURPOSE SECTION

XtraCare (salicylic acid) deep cleaning astringent

  • cleans deep
  • treats acne
  • helps prevent pimples

Compare to Clean & Clear® Deep Cleaning Astringent

8 fl. oz. (237 mL)

salicylic acid deep cleaning astringent

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

INDICATIONS & USAGE SECTION

Use  for the treatment of acne

WARNINGS SECTION

Warnings For external use only

Flammable, keep away from open flame

When using this product

  • avoid contact with eyes. If contact occurs, immediately flush with water.
  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • cleanse the skin thoroughly before applying medication
  • moisten a cotton ball or pad cover the entire
  • affected rea with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a physician. If bothersome drying or peeking occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, alcohol, PEG-40 hydrogenated castor oil, fragrance, aloe barbadensis leaf juice, d&c red no.33

OTHER SAFETY INFORMATION

*This product is not manufactured or distributed by Johnson&Johnson, the distributor of clean&clear®deep cleansing astringent.

DISTRIBUTED BY: 

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN4
346298salicylic acid 0.02 MG/MG Topical GelSCD4
346298salicylic acid 2 % Topical GelSY4

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
57337-035-012024-02-28C16284748780-11030e365-3cf6-111a-e063-dadaa90a10e2XtraCare Deep Cleaning Astringent
57337-035-012024-01-30C16284748780-11030e365-3cf6-111a-e063-dadaa90a10e2XtraCare Deep Cleaning Astringent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-035-01XtraCare Deep Cleaning Astringent237 mg in 1 BOTTLEGEL2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-035XTRACARE DEEP CLEANING ASTRINGENT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]4Current NDC, Legacy NDC, 1 package rows20240229_20cb8584-8a31-40a8-8a47-d9fa8ec8abcf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L2
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-03557337-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
POLYOXYL 40 CASTOR OIL4ERD2076EFIACT
ALOE VERA LEAFZY81Z83H0XIACT
D&C RED NO. 339DBA0SBB0LIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
POLYOXYL 40 CASTOR OILPEG-40 CASTOR OIL4ERD2076EFTABLET / ORAL9 mgExact identifier — unii candidate
2 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
XtraCare Deep Cleaning AstringentSALICYLIC ACIDRejoice International20cb8584-8a31-40a8-8a47-d9fa8ec8abcf2024-02-28WarningsExact identifier
ndc (package): 57337-035-01
ndc (product): 57337-035
ndc11 (package): 57337003501
spl id: 126cda9b-1f5b-3a25-e063-6294a90a691c
spl set id: 20cb8584-8a31-40a8-8a47-d9fa8ec8abcf

Reported adverse events (FAERS/openFDA)#

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