Label: BIORE BAKING SODA ACNE SCRUB- salicylic acid gel

  • NDC Code(s): 10596-183-10, 10596-183-45, 10596-183-56
  • Packager: Kao USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 31, 2017

If you are a consumer or patient please visit this version.

  • 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)

    10596-183-45-UPDATED

  • INGREDIENTS AND APPEARANCE
    BIORE  BAKING SODA ACNE SCRUB
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10596-183
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.5 g  in 127 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10596-183-45127 g in 1 TUBE; Type 0: Not a Combination Product12/01/2016
    2NDC:10596-183-1028 g in 1 TUBE; Type 0: Not a Combination Product12/01/2016
    3NDC:10596-183-56159 g in 1 TUBE; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2016
    Labeler - Kao USA Inc. (004251617)