Label: R-044 BLEMISH FIX- 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 January 5, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Salicylic Acid 2.0%

  • Purpose

    Acne treatment

  • Uses

    • penetrates pores to clear most acne blemishes. Helps keep skin clear of pimples.
  • Warnings

    For external use only.

    Using other acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Keep out of reach of children.

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

  • Directions

    • Cleanse the skin thoroughly before applying medication.
    • Shake well before use.
    • Apply a thin layer directly to affected areas one to three times daily.
  • Inactive Ingredients

    Camphor, Hamamelis Virginiana (Witch Hazel) Extract, SD Alcohol 40, Water (Aqua)

  • PRINCIPAL DISPLAY PANEL - 6.8 mL Carton

    blemish fix

    OIL - FREE
    SYSTEM

    .23 fl Oz / 6.8 mL

    Principal Display Panel - 6.8 mL Carton
  • INGREDIENTS AND APPEARANCE
    R-044 BLEMISH FIX 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24623-044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24623-044-236.8 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D03/28/2006
    Labeler - CBI Laboratories, Inc (623704368)
    Establishment
    NameAddressID/FEIBusiness Operations
    CBI Laboratories, Inc.623704368MANUFACTURE
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