FDA.reportPublic FDA data

Acne Body Wash

Manufacturer
Rejoice International | China Ningbo Shangge Cosmetic Technology Corp.
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:09:08

Label at a glance#

ProductAcne Body Wash
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                     Purpose

Salicylic Acid 2% ............Acne Treatment

OTC - PURPOSE SECTION

XtraCare 

ACNE Body Wash

Salicylic Acid

Acne Medication

  • helps to fight body acne
  • for refresh & clean skin
  • enriched with aloe vera

*Compare to Active Ingredients in Neutrogena Body Clear Body Wash

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.

INDICATIONS & USAGE SECTION

XtraCare Acne Body wash is refreshing, clean-rinsing body wash that helps fight acne on your back, chest, and shoulders. The foaming lather rinses completely without pore-clogging residue, leaving your skin feeling clean.

Use

for the treatment of acne.

DOSAGE & ADMINISTRATION SECTION

Directions: Use daily in the shower or bath.  For maximum lather, massage over wet skin with a washcloth or body puff, concentrating on areas prone to breakouts. Rinse well.

WARNINGS SECTION

Warning: for external use only.

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

OTHER SAFETY INFORMATION

Other information: Store at room temperature.

*this product is not manufactured of distributed by Neutrogena Corp., owner of the registered trademark Body Clear® Body Wash.

Distributed By:

REJOICE INTERNATIONAL INC.

NORTHVILLE, MI 48168, USA

MADE IN CHINA

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, disodium cocoamphodiacetate, glycerin, cocamide MEA, fragrance, citric acid, aloe barbadensis leaf extract, methylchloroisothiazolinone, methylisothiazoline, FD&C yellow no.5, D&C red no.33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN6
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD6
562600salicylic acid 2 % Facial Cleanser TonerSY6
562600salicylic acid 2 % Facial ScrubSY6
562600salicylic acid 2 % Medicated Liquid SoapSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-030-012024-02-28C16284748780-11030e365-126c-111a-e063-dadaa90a10e2Acne Body Wash
57337-030-012024-01-30C16284748780-11030e365-126c-111a-e063-dadaa90a10e2Acne Body Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-030-01Acne Body Wash354 mg in 1 BOTTLEGEL3546

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-030ACNE BODY WASH (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]6Current NDC, Legacy NDC, 1 package rows20240229_97369cca-735a-425f-a0bc-00bc07691465.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX4
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146D4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L4
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51M4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA4
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5U4
WATERINACTIVE INGREDIENT059QF0KO0R4

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
57337-03057337-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
GLYCERINPDC6A3C0OXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 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
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
COCO MONOETHANOLAMIDECOCO MONOETHANOLAMIDEC80684146DSHAMPOO / TOPICAL4 %w/wExact identifier — unii+route
2 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
6 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii+route
6 equally ranked IID candidates
COCO MONOETHANOLAMIDECOCO MONOETHANOLAMIDEC80684146DSHAMPOO / TOPICAL4 %w/wExact identifier — unii+route
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route
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
Acne Body WashSALICYLIC ACIDRejoice International97369cca-735a-425f-a0bc-00bc076914652024-02-28WarningsExact identifier
ndc (package): 57337-030-01
ndc (product): 57337-030
ndc11 (package): 57337003001
spl id: 126babfe-2f76-9f6c-e063-6294a90ae8e7
spl set id: 97369cca-735a-425f-a0bc-00bc07691465

Reported adverse events (FAERS/openFDA)#

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