R-044 BLEMISH FIX (SALICYLIC ACID) LIQUID [CBI LABORATORIES, INC]

R-044 BLEMISH FIX (SALICYLIC ACID) LIQUID [CBI LABORATORIES, INC]
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NDC 24623-044-23
Set ID 2c54d645-23eb-4159-baf3-0b386da2c999
Category HUMAN OTC DRUG LABEL
Packager CBI Laboratories, Inc
Generic Name
Product Class
Product Number
Application Number PART333D
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients

    Salicylic Acid 2.0%

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  • Purpose

    Acne treatment

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  • Uses

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

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  • 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.
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  • Inactive Ingredients

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    R-044 BLEMISH FIX 
    salicylic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24623-044
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24623-044-23 6.8 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 03/28/2006
    Labeler - CBI Laboratories, Inc (623704368)
    Establishment
    Name Address ID/FEI Business Operations
    CBI Laboratories, Inc. 623704368 MANUFACTURE
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