Label: CLARITY CLEAR SKIN ESSENTIALS FOAMING CLEANSER- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL

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 5, 2023

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  • Active ingredient

    Salicylic acid 0.5%

  • 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 this product use of other topical acne medications at the same time as or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless otherwise directed by a doctor.

    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 • cleanse skin twice a day on wet face • apply to hands, add water and work into a lather • massage face gently, rinse thoroughly • 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

  • INACTIVE INGREDIENT

    Inactive ingredients aloe barbadensis leaf juice powder, butylene glycol, citric acid, cucumis sativas (cucumber) fruit extract, disodium cocoamphodlacetate, fragrance, melaleuca alternifolia (tea tree) leaf oil, sodium C14-16 olefin sulfate, sodium citrate, sodium methyl cocoyl taurate, sodium PCA, tetrasodium EDTA, water

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CLARITY CLEAR SKIN ESSENTIALS  FOAMING CLEANSER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.691 g  in 133 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-222-04133 mL in 1 BOTTLE, PUMP; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-222)
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