BIORE MENS CHARCOAL ACNE SCRUB- salicylic acid gel

Biore by

Drug Labeling and Warnings

Biore by is a Otc medication manufactured, distributed, or labeled by Kao USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

ACTIVE INGREDIENT

Active ingredient

Salicylic acid 1%

PURPOSE

Purpose

Acne treatment

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only.

WHEN USING

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

Other information

store at room temperature

INACTIVE INGREDIENT

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

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)

INGREDIENTS AND APPEARANCE

BIORE  MENS CHARCOAL ACNE SCRUB
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ALUMINUM (UNII: CPD4NFA903)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
D&C RED NO. 30 (UNII: 2S42T2808B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TALC (UNII: 7SEV7J4R1U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SORBITOL (UNII: 506T60A25R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-192-45	127 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/01/2019

Labeler - Kao USA Inc. (004251617)