Label: CLARITY CLEAR SKIN ESSENTIALS ACNE TREATMENT- salicylic acid cream

  • 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 March 19, 2020

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  • Active ingredient

    Salicylic acid 2.0%

  • Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Use for the treatment and management of acne

  • Warnings

    For external use only. Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • WHEN USING

    When using this product skin irritaion and dryness is more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.

  • STOP USE

    Stop use and ask a doctor if excessive irritation of the skin develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ■ clean 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

  • STORAGE AND HANDLING

    Other information store at room temperature between 40°F and 90°F

  • INACTIVE INGREDIENT

    Inactive ingredients cetyl alcohol, cetearyl alcohol, ethylhexyl palmitate, glyceryl stearate, hydroxypropyl beta cyclodextrin, melaleuca alternifolia (tea tree) leaf oil, peg-100 stearate, polyglyceryl-3 methylglucose distearate, polysorbate 60, steareth-2, steareth-21, stearic acid, triethanolamine, water

  • PRINCIPAL DISPLAY PANEL

    tube label

  • INGREDIENTS AND APPEARANCE
    CLARITY CLEAR SKIN ESSENTIALS  ACNE TREATMENT
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.28 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-295-0114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/13/2012
    Labeler - Melaleuca Inc. (139760102)
    Registrant - Melaleuca Inc. (079711683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca Inc.079711683manufacture(54473-295)