Label: HYR ACNE WASH- benzoyl peroxide solution

  • NDC Code(s): 70481-330-06, 70481-330-12
  • Packager: General Resources LLC
  • 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 18, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzoyl Peroxide USP, 5%

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses
    for the treatment of acne

  • WARNINGS

    Warnings

    For external use only.

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with 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 by using the product less frequently or in a lower concentration
    • 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.

    Stop use and ask a doctor if irritation becomes severe

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well
    • wet affected area and apply product in a thin layer one to three times daily. Rinse well and pat dry.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor.
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • if going outside, use a sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients carbomer, purified water, sodium benzoate, sodium C14-16 olefin sulfonate, stearic acid

  • SPL UNCLASSIFIED SECTION

    Distributed by: General Resources • 227 S Smith Rd Suite 102 • Tempe, AZ 85281 • www.gen-resources.com

  • PRINCIPAL DISPLAY PANEL

    HYR

    ACNE WASH

    Benzoyl Peroxide USP, 5%

    Net 2 fl oz (60 ml)

    Proudly made in the USA

    Acne-BP-v3

  • INGREDIENTS AND APPEARANCE
    HYR ACNE WASH 
    benzoyl peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70481-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70481-330-0660 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
    2NDC:70481-330-12120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/19/2020
    Labeler - General Resources LLC (117648210)