BIORE BLUE AGAVE BAKING SODA ACNE CLEANSING FOAM- salicylic acid suspension

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

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Salicylic acid 0.5%

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

STORAGE AND HANDLING

Other information

store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

water, sodium c14-16 olefin sulfonate, sorbitol, polysorbate 20, laureth-4 carboxylic acid, sodium laureth sulfate, ethyhexylglycerin, citric acid, fragrance, sodium hydroxide, polyquaternium-39, disodium EDTA, sodium bicarbonate, agave tequilana leaf extract, sodium benzoate

SPL UNCLASSIFIED SECTION

Questions? 1-888-BIORE-11

www.biore.com

www.facebook.com/

@bioreskin

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2018

Made in Canada

PRINCIPAL DISPLAY PANEL

Biore

free your pores!

BLUE AGAVE + BAKING SODA

GREAT FOR COMBINATION SKIN

gentle foam targets acne & deep cleans pores

ACNE CLEANSING FOAM

SALICYLIC ACID ACNE TREATMENT

skin purifying technology/oil-free

acne's outta here!

NET WT 6.77 FL. OZ. (200 mL)

INGREDIENTS AND APPEARANCE

BIORE  BLUE AGAVE BAKING SODA ACNE CLEANSING FOAM
salicylic acid suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SORBITOL (UNII: 506T60A25R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-190-67	200 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/22/2019

Labeler - Kao USA Inc. (004251617)