FDA.reportPublic FDA data

Just4U Oil Free Acne Wash

Manufacturer
Sante Manufacturing Inc
Effective date
2022-08-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:55:58

Label at a glance#

ProductJust4U Oil Free Acne Wash
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Salicylic Acid - 2.0% w/w...........Acne Treatment

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use:

INDICATIONS & USAGE SECTION

For the treatment of acne.

WARNINGS SECTION

Warnings

For external use only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Cleanse twice a day

Wet face, apply to hands, add water and work into a lather

Massage face gently

Rinse thoroughly

OTHER SAFETY INFORMATION

Store at room temperature.

QUESTIONS

OTC - QUESTIONS SECTION

Made in Canada, Sante Manufacturing Inc.

Other Ingredients:

INACTIVE INGREDIENT SECTION

water, Cocamidopropyl betaine, sodium C14-16 Olefin Sulfonate, sodium laureth sulfate, propylene glycol, tetrasodium EDTA, Fragrance, Aloe, benzalkonium chloride, yellow 5, red 40, red 4.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
71020-01971020-019-23

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
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
ALOEV5VD430YW9IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C RED NO. 4X3W0AM1JLXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BASIC YELLOW 507BP340B4TIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
0fb70976-9a7b-76a0-e063-6294a90ab642bdb291d3-e581-d634-e053-2a95a90a52112024-01-24WarningsExact identifier
spl set id: bdb291d3-e581-d634-e053-2a95a90a5211

Reported adverse events (FAERS/openFDA)#

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