Label: LIQUID- salicylic acid liquid

  • NDC Code(s): 61354-091-01, 61354-091-02
  • 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 March 22, 2023

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  • Active Ingredient

    Salicylic Acid

  • Purpose

    Acne Treatment

  • Uses

    For the treatment of acne

    Helps prevent new acne blemishes from forming

  • Warnings

    For external use only

  • When using this product

    Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.

    Avoid contact with eyes. If products occurs, rinse eyes thoroughly with water

  • Keep out of reach of children

    If product is swallowed, get medical help or contact a poison control center immediately

  • Directions

    Shake well before use

    Start with damp skin

    Apply a small amount onto your fingertips and emulsify

    Gently cleanse the skin using circular motions

    Rinse with warm water and gently pat the skin dry

    Follow with your MONAT Skincare Routine

  • Inactive Ingredients

    Water/Aqua, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Propanediol, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Niacinamide, Cocamide MIPA, Glycerin, PEG-150 Distearate, Stearic Acid, Coconut Acid, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, PEG-120 Methyl Glucose Dioleate, Caprylyl/Capryl Glucoside, Polyglyceryl-10 Laurate, Polyglyceryl-10 Oleate, Sodium Chloride, SOdium Benzoate, Potassium Sorbate

  • Package Label

    61354-091-01_AW61354-091-01_AW

  • INGREDIENTS AND APPEARANCE
    LIQUID 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) 4.2 mg  in 100 mg
    PROPANEDIOL (UNII: 5965N8W85T) 2.99 mg  in 100 mg
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) 2 mg  in 100 mg
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) 0.56 mg  in 100 mg
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.79 mg  in 100 mg
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) 1.68 mg  in 100 mg
    WATER (UNII: 059QF0KO0R) 78.25 mg  in 100 mg
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) 1.087 mg  in 100 mg
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 0.5 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-091-021 in 1 CARTON03/22/2023
    1NDC:61354-091-011 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00603/22/2023
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-091)
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