Label: MIST- 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 February 10, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Salicylic Acid.... 0.5%

  • Purpose

    Acne Treatment

  • Use

    Use for treatment of acne

  • Warnings

    For external use only

    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

    Holding about six inches away from the face, spritz generously onto a clean, dry face and neck. Use both AM and PM after cleaning and before applying serums, moisturizers, and SPF.

  • 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.

  • Primary Package

    Bottle Bottle_AW

  • Secondary Package

    CARTON_AW

  • INGREDIENTS AND APPEARANCE
    MIST 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78999-007
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78999-007-011 in 1 CARTON03/09/2021
    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 finalpart333D03/09/2021
    Labeler - CLEAN SKIN CLUB (074934772)
    Establishment
    NameAddressID/FEIBusiness Operations
    OXYGEN DEVELOPMENT, LLC137098492manufacture(78999-007)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!