FDA.reportPublic FDA data

Spot Acne Treatment Oil Free 0.75oz

Manufacturer
Rejoice International Corp. | China Ningbo Shangge Cosmetics Technology Corp.
Effective date
2024-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:37

Label at a glance#

ProductSpot Acne Treatment Oil Free 0.75oz
Active ingredientSALICYLIC ACID
Label structure8 sections

Dosage and administration

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor. If some drynesss or peeling occurs, reduce application to once a day or every other day. If going outside, apply suns...

Storage and handling

Store at 20°C-25°C (68°F-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical cene medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Do not use if you

OTC - DO NOT USE SECTION

Do not use if you have very sentitive skin.

When using this product

OTC - WHEN USING SECTION

  • avoid unnessary sun exposure and use sunscreen.
  • avoid contact with eyes, lips, and mouth.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or a lower concentration.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severer.

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

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor.
  • If some drynesss or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 20°C-25°C (68°F-77°F)

Inactive gredients

INACTIVE INGREDIENT SECTION

Water

Alcohol

Phenyl Trimethicone

C13-14 Isoparaffin

Laureth-7

Polyacrylamide

Glycerin

Hamamelis Virginiana (Witch Hazel) Exact

Polysorbate 20

Phenoxyethanol

Propylene Glycol

Xanthan Gum

Fragrance

Cyclopentasiloxane

C12-15 Alkyl Lactate

Cetyl Lactate,

PPG-2 Isoceteth-20 Acetate

Myristamidopropyl PG-dimonium Chloride Phosphate

Benzalkonium Chloride,

Disodium EDTA,

Butylene Glycol,

Capryloyl Glycine,

Sarcosine

Cinnamomum Zeylanicum Bark Extract,

Cedrus Atantica Bark Extract,

Portulaca Oleracea Extact

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN1
317152salicylic acid 20 MG/ML Topical CreamSCD1
317152salicylic acid 2 % Topical CreamSY1

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-168-01Spot Acne Treatment Oil Free 0.75oz21 g in 1 TUBECREAM211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-168SPOT ACNE TREATMENT OIL FREE 0.75OZ (SALICYLIC ACID) CREAM [REJOICE INTERNATIONAL CORP.]1Current NDC, 1 package rows20240904_212f77ca-82d3-6a78-e063-6394a90aed32.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57337-16857337-168-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
PURSLANEM6S840WXG5IACT
EDETATE DISODIUM7FLD91C86KIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CINNAMON BARK OILXE54U569ECIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
LAURETH-7Z95S6G8201IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MYRISTAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEE4821CQM1IIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CETYL LACTATEA7EVH2RK4OIACT
PPG-2 ISOCETETH-20 ACETATEBI6C7YO419IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
POLYSORBATE 207T1F30V5YHIACT
XANTHAN GUMTTV12P4NEEIACT
C12-15 ALKYL LACTATEGC844VRD7EIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
CEDRUS ATLANTICA BARKITP1Q41UPFIACT
SARCOSINEZ711V88R5FIACT
SALICYLIC ACIDO414PZ4LPZACTIB
GLYCERINPDC6A3C0OXIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE)9FPL31B58QIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACIDRejoice International Corp.212f77ca-82d3-6a78-e063-6394a90aed322024-09-02WarningsExact identifier
ndc (package): 57337-168-01
ndc (product): 57337-168
ndc11 (package): 57337016801
spl id: 212f77ca-82d4-6a78-e063-6394a90aed32
spl set id: 212f77ca-82d3-6a78-e063-6394a90aed32

Reported adverse events (FAERS/openFDA)#

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