Label: MIZON ACENCE BLEMISH OUT PINK SPOT- salicylic acid solution

  • 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 August 25, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Salicylic Acid 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Alcohol, Water, Calamine, Glycerin, Titanium Dioxide(CI77891), Glycolic Acid, Dimethyl Sulfone, Camphor, Peg-60 Hydrogenated Castor Oil, Rubus Idaeus(Raspberry) Fruit Extract, Propylene Glycol, Butylene Glycol, Coptis Chinensis Root Extract, Portulaca Oleracea Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Saccharum Officinarum(Sugar Cane) Extract, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Citrus Medica Limonum(Lemon) Fruit Extract, Citrus Aurantium Dulcis(Orange) Fruit Extract, Acer Saccharum(Sugar Maple) Extract, Pinus Pinaster Bark/Bud Extract, Hedera Helix(Ivy) Extract, Citrus Grandis(Grapefruit) Peel Oil

  • PURPOSE

    Purpose: Blemish Treatment

  • WARNINGS

    Warnings: 1. For external use only. 2. Avoid contact with eyes and mouth. 3. Discontinue use if signs of irritation or rashes appear. 4. Replace the cap after use. 5. If ingestion occurs, give victim water and seek medical attention.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions for use

    Directions for use: Cleanse face thoroughly using face wash. Without shaking, use a cotton swab to dip to the bottom and apply directly to only blemishes and trouble spots overnight. Wash off with face wash the following morning.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Use on blemishes or pimples once daily. If excessive dryness or irritation occurs, discontinue use and consult your doctor.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MIZON ACENCE BLEMISH OUT PINK SPOT 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.15 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57718-060-0130 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2015
    Labeler - MIZON CO., LTD. (557815570)
    Registrant - MIZON CO., LTD. (557815570)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIZON CO., LTD.557815570repack(57718-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd.689835593manufacture(57718-060)
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