Label: CLARITY CLEAR SKIN ESSENTIALS DEEP-CLEANING ASTRINGENT- salicylic acid 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 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 skin irritation and dryness is more likely to occur if you use another topical acne medicationat the same time. 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 • clean skin thoroughly before applying this product • moisten a cotton ball, 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

  • INACTIVE INGREDIENT

    Inactive ingredients allantoin, aloe barbadensis leaf juice powder, butylene glycol, camellia oleifera (green tea) leaf extract, chamomillia recuttia (matricaria) flower extract, fragrance, hamamelia virginiana (witch hazel) extract, melaleuca alternifolia (tea tree) leaf oil, menthol panthenol, pentylene glycol, polyquaternium-7 propandiol, PPG-5-ceteth-20, SD alcohol 40-B, sodium citrate, water, zinc PCA

  • PRINCIPAL DISPLAY PANEL

    astringentbck.jpgastringentfrt.jpg

  • INGREDIENTS AND APPEARANCE
    CLARITY CLEAR SKIN ESSENTIALS  DEEP-CLEANING ASTRINGENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.623 g  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    MENTHOL (UNII: L7T10EIP3A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-221-04130 mL in 1 BOTTLE, PLASTIC; 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(54473-221)
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