FDA.reportPublic FDA data

Biore

Manufacturer
Kao USA Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:12

Label at a glance#

ProductBiore Witch Hazel Pore Clarifying Cleanser
Active ingredientSALICYLIC ACID
Label structure13 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

BIORE PORE CLARIFYING COOLING CLEANSER

This refreshingly cool formula works to deep clean by removing over 99% of blemish causing dirt and oil.

  • With Witch Hazel, known to tighten pores, purify, and refresh skin

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 2%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Uses

  • clears up acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming

WARNINGS SECTION

Warnings

For external use only.

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

  • wet face
  • pump product into hands
  • massage over entire face and neck
  • rinse thoroughly
  • for optimal results, use daily

STORAGE AND HANDLING SECTION

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, glycerin, sodium C14-16 olefin sulfonate, sodium laureth sulfate, coco-glucoside, cocamidopropyl betaine, betaine, lauric acid, PEG-7 glyceryl cocoate, glyceryl oleate, sodium hydroxide, fragrance, menthol, polyquaternium-7, BHT, disodium EDTA, hamamelis virginiana (witch hazel) water, eucalyptus globulus leaf extract, lavandula angustifolia (lavender) flower extract, alcohol

SPL UNCLASSIFIED SECTION

Questions?

1-888-BIORE-11

www.biore.com

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2018

Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biore

free your pores!

WITCH HAZEL

deep cleans, clarifies and refines pores

PORE CLARIFYING COOLING CLEANSER

SALICYLIC ACID ACNE TREATMENT

oil-free

acne's outta here!

6.77 FL OZ (200 mL)

10596-188 03-202110596-188 03-2021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN4
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD4
562600salicylic acid 2 % Facial Cleanser TonerSY4
562600salicylic acid 2 % Facial ScrubSY4
562600salicylic acid 2 % Medicated Liquid SoapSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-188-67BioreWitch Hazel Pore Clarifying Cleanser200 mL in 1 BOTTLE, WITH APPLICATORLIQUID2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-188BIORE WITCH HAZEL PORE CLARIFYING CLEANSER (SALICYLIC ACID) LIQUID [KAO USA INC.]4Current NDC, Legacy NDC, 1 package rows20250109_7c107414-457b-1ab0-e053-2991aa0af55a.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-18810596-188-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL OLEATE4PC054V79PIACT
WITCH HAZEL101I4J0U34IACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCO GLUCOSIDEICS790225BIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOLL7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZACTIB
BETAINE3SCV180C9WIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
LAURIC ACID1160N9NU9UIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
Biore Witch Hazel Pore Clarifying CleanserSALICYLIC ACIDKao USA Inc.7c107414-457b-1ab0-e053-2991aa0af55a2025-01-01WarningsExact identifier
ndc (package): 10596-188-67
ndc (product): 10596-188
ndc11 (package): 10596018867
spl id: 2b206d5a-487d-923b-e063-6294a90a13b5
spl set id: 7c107414-457b-1ab0-e053-2991aa0af55a

Reported adverse events (FAERS/openFDA)#

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