FDA.reportPublic FDA data

Biore

Manufacturer
KAO USA
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:43:26

Label at a glance#

ProductBiore
Active ingredientSALICYLIC ACID
Label structure9 sections

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 2%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Uses •For the treatment of acne

WARNINGS SECTION

Warnings

For external use only.

Flammable: Keep away from fire or flame

OTC - WHEN USING SECTION

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, rinse thoroughly with water

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Cleanse skin thoroughly before applying medication.
  • Cover the entire affected area with a thin layer 1 to 3 times daily using a cotton ball or pad.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

STORAGE AND HANDLING SECTION

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, alcohol denat., isopropyl alcohol, hamamelis virginiana (witch hazel) water, glycerin, polysorbate 20, sodium hydroxide, sodium citrate, alcohol, citric acid, tetrasodium glutamate diacetate

OTC - QUESTIONS SECTION

Questions? 1-888-BIORE-11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biore

CLEAR & BREATHABLE

WITCH HAZEL 2% BHA TONER

Salicylic Acid Acne Treatment

Questions? 1-888-BIORE-11 biore.com

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.,

Cincinnati, OH 45214 ©2022

Made in Canada

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-196BIORE (SALICYCLIC ACID) LIQUID [KAO USA]2Unmatched20250109_f6dfaa8f-1671-1460-e053-6394a90aa67c.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-19610596-196-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WITCH HAZEL101I4J0U34IACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT

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
4744ba7d-271b-f5ed-e063-6294a90a052ff6dfaa8f-1671-1460-e053-6394a90aa67c2025-12-31WarningsExact identifier
spl set id: f6dfaa8f-1671-1460-e053-6394a90aa67c

Reported adverse events (FAERS/openFDA)#

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