Label: CLEAROGEN 3- benzoyl peroxide lotion

  • NDC Code(s): 62742-4238-1, 62742-4238-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient

    Benzoyl Peroxide 2.5%

  • PURPOSE

    Purpose- Acne Treatment

  • INDICATIONS & USAGE

    Uses. For the treatment of acne

  • WARNINGS

    Warning : For external use only

  • DO NOT USE

    Avoid unnecessary sun exposure and use sunscreen.

  • WHEN USING

    Avoid contact with eye, If product gets into eyes, rinse thoroughly with water.

  • STOP USE

    If excessive irritation occurs reduce application to once a day. Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Direction:

    After cleansing and toning apply lotion over the entire face. Use daily. If going outside use a sunscreen

    Allow Clearogen to dry then follow directions in the sunscreen labeling. If irritation or sensitivity develops, discontinue use of all products, and consult a doctor.

  • OTHER SAFETY INFORMATION

    Not applicable

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Aqua (Water), Linolenic Acid (Alpha & Gamma), Linoleic Acid,Glycerin, Glycine Soja (Soyabean) Sterols, Dodecyl Gallate, Octyl Ethylhexyl Gallate, Serenoa Serrulata Fruit Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol & Dicetyl Phosphate & Ceteth-10 Phosphate, Dimethicone, Aloe Barbadensis Leaf Extract, Glyceryl Stearate & PEG-100 Stearate, Sodium Hyaluronate, Cetyl Alcohol, Caprylyl Glycol, Phenoxyethanol,Extract of Malva Sylvestris (Mallow), Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Imperata Cylindrica Root Extract, Stearic Acid, Symphytum Officinale Extract, Camellia Oleifera(Green Tea)Leaf Exact, Tocopherol, Plantago Ovata Seed Extract, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Melia Azadirachta Leaf Extract, Chamomilla Recutita Flower Exact, Xanthan Gum, Ethylhexyl glycerin, Sulfur, Disodium EDTA, Magnesium Aluminum Silicate, Hexylene Glycol.

  • PRINCIPAL DISPLAY PANEL

    Acne lotion acne treatment BPO

  • INGREDIENTS AND APPEARANCE
    CLEAROGEN 3 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PLANTAGO OVATA SEED (UNII: UD50RBY30F)  
    WATER (UNII: 059QF0KO0R)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PRIMULA VERIS (UNII: W6LFQ57E4M)  
    ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYL GALLATE (UNII: O14R793D1H)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SULFUR (UNII: 70FD1KFU70)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    DODECYL GALLATE (UNII: 45612DY463)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    SOY STEROL (UNII: PL360EPO9J)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4238-155 g in 1 TUBE; Type 0: Not a Combination Product12/06/2023
    2NDC:62742-4238-230 g in 1 TUBE; Type 0: Not a Combination Product12/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/06/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4238)