BIORE BAKING SODA 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 BAKING SODA ACNE SCRUB unclogs pores and balances skin to reduce breakouts.

• with Natural Baking Soda

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.

WHEN USING

When using this product

• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• avoid contact with eyes. If this 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, sodium cocoyl isethionate, glycerin, glycol disearate, synthetic wax, ethoxydiglycol, PEG-6 caprylic/capric glycerides, microcrystalline wax, cetyl alcohol, PEG-12 dimethicone, sodium lauroyl lactylate, sodium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, xanthan gum, sodium benzoate, fragrance, menthol, sodium bicarbonate, benzophenone-4, yellow 5 lake, talc, red 30

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 ©2017

Made in USA of US & imported ingredients

PRINCIPAL DISPLAY PANEL

Biore

free your pores!

BAKING SODA!

GREAT FOR COMBINATION SKIN

gently exfoliates & clears acne

BAKING SODA ACNE SCRUB

SALICYLIC ACID ACNE TREATMENT

pH balanced/oil-free

acne's outta here!

NET WT 4.5 OZ (127 g)

INGREDIENTS AND APPEARANCE

BIORE  BAKING SODA ACNE SCRUB
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10596-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.5 g  in 127 g

Inactive Ingredients
Ingredient Name	Strength
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
BENZOPHENONE (UNII: 701M4TTV9O)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
D&C RED NO. 30 (UNII: 2S42T2808B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10596-183-45	127 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2016
2	NDC: 10596-183-10	28 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2016
3	NDC: 10596-183-56	159 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2016

Labeler - Kao USA Inc. (004251617)