Label: CLARIFAST ONE STEP ACNE TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 0.5 %

    Purpose

    Acne Treatment

  • Uses:

    • For the treatment of acne. • Helps clear acne blemishes, pimples, and blackheads. • Penetrates pores to reduce the number of acne blemishes, pimples and blackheads. • Helps prevent new acne blemishes, pimples, and blackheads from forming. • Helps prevent the development of new acne blemishes, pimples and blackheads.



  • Warnings:

    for external use only.

    When using this product: 

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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Apply to affected area and rub in lightly, one to two times daily (before bedtime or anytime during the day as desired). Allow 30 minutes to dry • If drying of the skin occurs, reduce application to once a day, every other day, or as directed by a doctor.

  • Other information:

    • Protect the product in this container from excessive heat and direct sun. Store at a controlled room temperature 20-25C (68-77F).

  • Inactive ingredients:

    Alpha-GEE®, Aloe Barbadensis Leaf Extract, Amezol®, Bellis Perennis Flower Extract, Cetyl Alcohol, Coconut Oil, Colloidal Oatmeal,  Denatured  Alcohol, Glyceryl Monostearate, Hamamelis Virginiana Extract 3X, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polyethylene Glycol 400, Polyethylene Glycol 3350, Potassium Phosphate Dibasic, Propylene Glycol, Sulfur 1X, Zinc Oxide.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    CLARIFAST ONE STEP ACNE TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82908-358
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OATMEAL (UNII: 8PI54V663Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82908-358-0081.33 mL in 1 JAR; Type 0: Not a Combination Product08/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/08/2022
    Labeler - VIREO SYSTEMS, INC. (832940295)
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