Label: 30 DAY ACNE TREATMENT KIT- salicylic acid, benzoyl peroxide kit

  • NDC Code(s): 56152-0250-1, 56152-0251-1, 56152-0252-1
  • Packager: Cosmetic Enterprises Ltd
  • 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 August 23, 2023

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

  • Acne Cleanser

    Active ingredients Purpose

    Salicylic Acid 0.5% Acne Medication

  • Acne Lotion

    Active Ingredient Purpose

    Benzoyl Peroxide 5% Acne treatment

  • PURPOSE

    Use - For the Treatment of acne

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center immdiately.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if irritation becomes severe.

  • Acne Cleanser

    Warnings:

    For external use only

    when using this product

    • 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 medication at a time.
    • Avoid contact with eyes, If contact occurs, flush thoroughly with water.
  • Acne Lotion

    Warnings:

    • For external use only
    • Do not use if you
    • have very sensitive skin
    • are sensitive to benzoyl peroxide.
    • When using this product
    • 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 medication at a time
    • Avoid unnecess 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 lower concentration.
  • Acne Cleanser

    Directions:

    • Cleanse twice a day.
    • Wet face. Apply to hands, add water and work into lather.
    • Massage Face gently.
    • Rinse thoroughly.
  • Acne Lotion

    Directions:

    • Clean 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 directed by a doctor
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • If going outside, apply a sunscreen after using this product
    • If irritation or sensitivity develops, stop use of both products and ask a doctor
  • Acne Cleanser

    Inactive ingredients:

    Water, Decyl Polyglucose, Laurel Glucoside, Cocamidopropyl Betaine, Glycerin, Xanthan Gum, Sodium Cocoyl Hydrolized Amaranth Protein, Malaleuca Alternifolia (Australian Tea Tree) Leaf Extract, Polysorbate 20, Backhousia Citriodora (Australian Myrtle) Leaf Extract, Fusanus Spicatus (Australian Sandalwood) Extract, Disodium EDTA.

  • Acne Lotion

    Inactive Ingredients:

    Water, Dimethicone,Cetyl Alcohol, Propylene Glycol, Polyacrylate 13/polyisobutene/ Polysorbate 20, Cocamidopropyl Betaine, Glycerin, Backhouseia Citriodora (Australian Myrtle) Leaf Extract, Fusanus Spicatus (Australian Sandalwood) Extract, Aloe Barbadensis Leaf Juice, Sodium Benzoate, Pentylene Glycol, C12-15 Alkyl Benzoate, Phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

    Organiclear Acne Kit

    Acne Kit drug facts

  • INGREDIENTS AND APPEARANCE
    30 DAY ACNE TREATMENT KIT 
    salicylic acid, benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-0250
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-0250-11 in 1 KIT; Type 0: Not a Combination Product08/23/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 90 mL
    Part 2
    Part 31 TUBE 180 mL
    Part 1 of 3
    ORGANICLEAR ACNE 
    benzoyl peroxide lotion
    Product Information
    Item Code (Source)NDC:56152-0251
    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
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-0251-190 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/23/2023
    Part 2 of 3
    ORGANICLEAR SOOTHING LOTION 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRMELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRMATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRBACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
    INGRSANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRLACTIC ACID (UNII: 33X04XA5AT)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/24/2023
    Part 3 of 3
    ORGANICLEAR ACNE CLEANSER 
    salicylic acid cream
    Product Information
    Item Code (Source)NDC:56152-0252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    SANTALUM SPICATUM WHOLE (UNII: O8PUT104O1)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56152-0252-1180 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/23/2023
    Labeler - Cosmetic Enterprises Ltd (017701475)