Label: SOLIMO REPAIRING TREATMENT FOR ACNE PRONE SKIN- benzoyl peroxide liquid

  • NDC Code(s): 72288-525-01, 72288-525-02
  • Packager: Amazon.com Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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

  • Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

    Purpose

    Acne treatment gel

  • Uses

    • for the management of acne
  • Warnings

    For external use only.

    When using this product:

    • do not use this product more than three times per day.
    • skin irritation and dryness are 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 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 by using the product less frequently or in a lower concentration.

    Do not use

    if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    Stop use and ask a doctor if

    • irritation becomes severe.

    Keep out of reach of children.

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

  • Directions

    • Apply product sparinglyto one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. Sensitivity Test for a New User:
    • cleanse the skin thoroughly before applying this product.
    • cover the entire affected area with a thin layer one to three times daily.
    • 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 as directed by a doctor. 
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Inactive Ingredients

    Water, ceteareth-20, propylene glycol, cetearyl alcohol, carbomer, ethoxydiglycol, cyclotetrasiloxane, glyceryl stearate, dimethicone, xanthan gum, peg-100 stearate, allantoin, panthenol, cyclopentasiloxane, fragrance, imidazolidinyl urea, methylparaben, propylparaben, sodium hydroxide.

  • Package Labeling:1oz

    Label

  • Package Labeling:2oz

    2oz

  • INGREDIENTS AND APPEARANCE
    SOLIMO REPAIRING TREATMENT FOR ACNE PRONE SKIN 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-525
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-525-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    2NDC:72288-525-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/30/2020
    Labeler - Amazon.com Services LLC (128990418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(72288-525)