FDA.reportPublic FDA data

LABOFLEX Acne Spot Care

Manufacturer
Laboflex, Inc. | WOOSHIN LAPACHE d.o.o.
Effective date
2023-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:25:22

Label at a glance#

ProductLABOFLEX Acne Spot Care
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne

Dosage and administration

Cleanse thoroughly before applying this product Cover the entire affected area with patch Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or even every other day

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse thoroughly before applying this product
  • Cover the entire affected area with patch
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or even every other day

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Methyl- paraben, Mint Oil, Partially Neutralized Polyacrylic Acid, Polysorbate 80, Povidone-K90, Propylparaben, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water

Questions of comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children

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

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

CartonCartonLabelLabel

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83655-10583655-105-21, 83655-105-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
SALICYLIC ACIDO414PZ4LPZACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
MINTFV98Z8GITPIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
WATER059QF0KO0RIACT
TARTARIC ACIDW4888I119HIACT
POVIDONE K90RDH86HJV5ZIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE SODIUMMP1J8420LUIACT

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
28548382-cb72-9bf5-e063-6394a90ad98a06987b0d-a8f7-82e7-e063-6394a90aa7e12024-12-02WarningsExact identifier
spl set id: 06987b0d-a8f7-82e7-e063-6394a90aa7e1

Reported adverse events (FAERS/openFDA)#

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