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

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 June 22, 2020

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  • 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

    • Sensitivity Test for a New User: Apply product sparinglyto one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
    • 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 finalpart333D07/30/2020
    Labeler - Amazon.com Services LLC (128990418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(72288-525)
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