Label: MIST- salicylic acid liquid

  • NDC Code(s): 61354-092-01
  • Packager: OXYGEN DEVELOPMENT, LLC
  • 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 June 14, 2023

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  • Active Ingredient

    Salicylic Acid.... 0.5%

  • Purpose

    Acne Treatment

  • Use

    Use for treatment of acne

  • Warnings

    For external use only

    Avoid contact with eyes

    Contact with eyes

    Avoid contact with eyes

    When using this product, skin irritation and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.

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

  • Directions

    Use once daily for treatment on clean, dry skin and before serums, moisturizers, and SPF. Recommended for PM use only. To use, mist evenly over your face, neck, and other affected areas.

  • Inactive Ingredients

    Water/Aqua, Sodium Benzoate, Sodium Polyacrylate, Caprylyl/Capryl Glucoside, Potassium Sorbate, Eucalyptus Globulus Leaf Oil, Glycerin, Salix Alba (Willow) Bark Extract, Rosa Damascena Flower Extract, Citric Acid, achillea Milefolium Flower Extract, Glucose, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

  • When using this product

    When using this product, skin irritation, and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.

  • Keep out of reach of children

    If swallowed, seek medical help or contact Poison Control right away

  • Primary Package

    61354-092_aw

  • Secondary Package

    61354-092-01_aw

  • INGREDIENTS AND APPEARANCE
    MIST 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    WATER (UNII: 059QF0KO0R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-092-011 in 1 CARTON06/14/2023
    1100 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/14/2023
    Labeler - OXYGEN DEVELOPMENT, LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    OXYGEN DEVELOPMENT, LLC137098492manufacture(61354-092)
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