BIORE WITCH HAZEL PORE CLARIFYING TONER- salicylic acid liquid

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 2%

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.

Flammable: Keep away from fire or flame.

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

• 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 one 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.

STORAGE AND HANDLING

Other information

store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

water, alcohol denat., isopropyl alcohol, hamamelis virginiana (witch hazel) water, glycerin, polysorbate 20, sodium hydroxide, sodium citrate, alcohol, citric acid, menthol, benzophenone-4, disodium EDTA, fragrance.

SPL UNCLASSIFIED SECTION

what it does:

BIORE PORE CLARIFYING TONER teams up with Witch Hazel & Salicylic Acid. This refreshing formula helps restore skin's balance as it penetrates and deep cleans pores for clear skin.

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

PRINCIPAL DISPLAY PANEL

Biore

free your pores!

WITCH HAZEL

controls oil & deep cleans for clear pores

PORE CLARIFYING TONER

SALICYLIC ACID ACNE TREATMENT

lightweight/oil-free

acne's outta here!

NET WT 8.0 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

BIORE  WITCH HAZEL PORE CLARIFYING TONER
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WITCH HAZEL (UNII: 101I4J0U34)
BENZOPHENONE (UNII: 701M4TTV9O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-187-80	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/18/2018

Labeler - Kao USA Inc. (004251617)