Label: SOLIMO RENEWING CLEANSER FOR ACNE PRONE SKIN- benzoyl peroxide liquid

  • NDC Code(s): 72288-526-02, 72288-526-04
  • Packager: Amazon.com Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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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

    • 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:
    • apply a small amount to dampened skin.
    • cover the entire affected area with a thin layer and rinse thoroughly 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, cetyl esters, sorbitol, propylene glycol, polyethylene, dimethyl isosorbide, magnesium aluminum silicate, tridecyl trimellitate, glyceryl stearate, xanthan gum, peg-100 stearate, disodium peg-12 dimethicone sulfosuccinate, tridecyl stearate, neopentylglycol dicaprylate/dicaprate, sodium pca, imidazolidinyl urea, fragrance, methylparaben, propylparaben, carthamus tinctorius (safflower) seed oil, sodium hyaluronate, chamomilla recutita (matricaria) flower extract.

  • Package Labeling: 2oz

    Bottle

  • Package Labeling: 4oz

    Bottle2

  • INGREDIENTS AND APPEARANCE
    SOLIMO RENEWING CLEANSER FOR ACNE PRONE SKIN 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-526
    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)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-526-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    2NDC:72288-526-04118 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(72288-526)
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