FDA.reportPublic FDA data

Biore

Manufacturer
Kao USA Inc.
Effective date
2019-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:18

Label at a glance#

ProductBiore Mens Charcoal Acne Scrub
Active ingredientSALICYLIC ACID
Label structure13 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

BIORE CHARCOAL ACNE CLEARING SCRUB cleans and exfoliates away acne-causing dirt and absorbs excess oil to help eliminate breakouts for clear skin.

  • with Natural Charcoal

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 1%

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 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
  • squeeze product into hands
  • massage over entire face
  • rinse thoroughly
  • for optimal results, use up to 2-3 times per week

STORAGE AND HANDLING SECTION

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Glycerin, Sodium Laureth Sulfate, Alumina, Cocamidopropyl Betaine, Sorbitol, Laureth-4 Carboxylic Acid, Synthetic Wax, Microcrystalline Wax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance, Sodium Hdroxide, Menthol, Polyquaternium-39, Charcoal Powder, Disodium EDTA, Talc, Sodium Benzoate,Red 30, Yellow 5 lake

SPL UNCLASSIFIED SECTION

Questions? 1-888-BIORE-11

www.biore.com @bioreus

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2019

Made in USA of US & Imported Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biore

free your pores!

MEN'S SKINCARE

CHARCOAL ACNE CLEARING SCRUB

scrubs out acne-causing dirt & oil

SALICYLIC ACID ACNE TREATMENT

NET WT 4.5 OZ (127 g)

10596-192-45-NEW10596-192-45-NEW

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1803724Biore 1 % Medicated Liquid SoapPSN1
1038982salicylic acid 1 % Medicated Liquid SoapPSN1
1803724salicylic acid 10 MG/ML Medicated Liquid Soap [Biore]SBD1
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD1
1803724Biore 1 % Medicated Liquid SoapSY1
1038982salicylic acid 1 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10596-192-452023-01-30C16284748780-1f386c649-aaf5-0266-e053-dadaa90a7c1aBiore Men's Skincare Charcoal Acne Clearing Scrub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-192-45BioreMens Charcoal Acne Scrub127 g in 1 TUBEGEL1271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-192BIORE MENS CHARCOAL ACNE SCRUB (SALICYLIC ACID) GEL [KAO USA INC.]1Legacy NDC, 1 package rows20191024_93b36ca1-d646-1e97-e053-2a95a90a88f9.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-19210596-192-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
ALUMINUMCPD4NFA903IACT
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW)X2NH1K9F8KIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SODIUM HYDROXIDE55X04QC32IIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHOLL7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZACTIB
D&C RED NO. 302S42T2808BIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
TALC7SEV7J4R1UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SORBITOL506T60A25RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
EDETATE DISODIUM7FLD91C86KIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
LAURETH-4 CARBOXYLIC ACIDDW3PIY647YIACT

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
93b36ca1-d638-1e97-e053-2a95a90a88f993b36ca1-d646-1e97-e053-2a95a90a88f92019-09-29WarningsExact identifier
spl id: 93b36ca1-d638-1e97-e053-2a95a90a88f9
spl set id: 93b36ca1-d646-1e97-e053-2a95a90a88f9

Reported adverse events (FAERS/openFDA)#

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