Label: CLN ACNE CLEANSER- salicylic acid 0.5% liquid

  • 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 January 23, 2015

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  • SPL UNCLASSIFIED SECTION

    ​Drug Facts

  • Active ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne

  • 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 on topical acne medication at a time.

    • ​Avoid contact with eyes.​  If contact occurs, flush thoroughly with water. 

    Keep out of reach of children.

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

  • Directions

    • Cleanse twice daily or as indicated by your physician
    • Treat whole area
    • Wet the skin
    • Dispense into wet hands
    • Massage area gently for 30 seconds working to create a lather
    • Rinse thoroughly with warm water
    • If bothersome dryness or peeling occurs, reduce use to once a day or every other day.
  • Inactive ingredients

    Purified Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, PEG-120 Methyl Glucose Trioleate (and) Propanediol, Sodium Hypochlorite, Disodium EDTA, Sodium Hydroxide

  • CLn Acne Cleanser

    CLn​®

    Think Clinically Clean™

    Skin Clarifying Acne Cleanser


    Clears and prevents breakouts for acne prone skin

    Dermatologist & clinically tested

    2.5 fl oz (75 mL)

    clnacnecleanser

  • CLn Dermatologics

    CLn​®

    Dermatologics

    Think Clinically Clean™

    Acne Cleanser

    0.5% salicylic acid acne treatment

    Clears and prevents breakouts for acne prone skin

    Dermatologist & Clinically Tested

    2.5 fl oz (75 mL)

    clndermacne

  • INGREDIENTS AND APPEARANCE
    CLN ACNE CLEANSER 
    salicylic acid 0.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69530-856
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69530-856-441 in 1 CARTON
    175 mL in 1 BOTTLE, PLASTIC
    2NDC:69530-856-451 in 1 CARTON
    275 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/01/2015
    Labeler - TopMD Skin Care (057871201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274manufacture(69530-856) , analysis(69530-856) , pack(69530-856)
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