Label: KIVORIA ACNE WASH- benzoyl peroxide soap

  • 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 12, 2020

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

  • Drug Facts

    Active Ingredient

    Benzoyl Peroxide 10%

    Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

  • When using this product

    • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time (if irritation occurs, use only one topcial acne medication at a time).
    • Avoid unnecessary sun exposure and use a sunscreen
    • Avoid contact with the eyes, lips, and mouth
    • Avoid contact with hair and dyed fabrics, which may be bleached by this product
    • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling
    • Irritation may be reduced byusing the product less frequently or in a lower concentration.
  • Do Not Use

    • If you have very sensitive skin
    • If you are sensitive to benzoyl peroxide
    • If safety evident features have been breached or missing
  • Stop use and ask a doctor

    • If irritation becomes more severe
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center.

  • Directions

    Sensitivity test for a new user: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, apply the acne wash and gently massage into damp skin. Wait 3 to 5 minutes to absorb, and then thoroughly rinse area with water. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use and ask a doctor.

  • Other Ingredients

    Aloe Barbadensis (aloe vera gel) Juice, Deionized Water, Ascorbic Acid (Vitamin C), Camella Sinensis (Green Tea) Leaf Extract, Carbomer, Cocamidopropyl Betaine, Gluconolactone, Sodium Benzoate, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Hydroxide, Thymus Vulgaris (Thyme) Extract.

  • Distributed by

    Uber Scientific, LLC

    3211 Vineland Rd. Suite 250

    (302) 566-8237

  • PDP

    KIVORIA Acne Wash

    10% Benzoyl Peroxide

    8fl oz | 226g

    Cruelty Free

    Made in USA

    Acne Wash Label

  • INGREDIENTS AND APPEARANCE
    KIVORIA ACNE WASH 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71131-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXIDE ION (UNII: 9159UV381P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71131-100-081 in 1 BOX04/01/2019
    1226 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/01/2019
    Labeler - UberScientific, LLC (080459429)
    Registrant - UberScientific, LLC (080459429)