Label: SALIC-2- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Salicylic Acid (2%)

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  • Purpose

    Acne Medication

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  • Uses For acne treatment

    • Reduces the number of whiteheads, blackheads and acne blemishes.
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  • Warnings

    For external use only

    When using this product

    • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation 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

    • Clean the skin thoroughly before applying product.
    • Cover the entire affected area with a thin layer one to three times daily.
    • Relax for 2-3 minutes, then rinse.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor.
    • If both dryness and peeling occurs, reduce application to once a day or every other day.
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  • Other information

    • Keep tightly closed
    • Store in a cool & dry place.
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  • Inactive ingredients

    Water, Propylene Glycol, Disodium Hydrogen Phosphate Anhydrous, Sodium Lauryl Sulphate, Chlorocresol, Carbopol 940, Fragrance SSC-929/BRH

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  • Questions ?

    1(856) 2863646

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  • SPL UNCLASSIFIED SECTION

    Distributed by :
    Sohm, Inc.

    6920 Knott Ave., Suite A-C
    Buena Park, CA 90621

    Manufactured by
    Sohm (India) Pvt. Ltd. India.

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  • PRINCIPAL DISPLAY PANEL - 60g Tube Label

    Salicylic Acid 2% Gel

    Acne Treatment
    A Complete Fresh Face Wash Gel

    Salic-2®

    Acne Control

    Exfoliating

    Age Defying

    Rejuvenating

    2.12 OZ 60g)

    PRINCIPAL DISPLAY PANEL - 60g Tube Label
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  • INGREDIENTS AND APPEARANCE
    SALIC-2 
    salicylic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50405-110
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (Salicylic Acid) Salicylic Acid 1.2 g  in 60 g
    Inactive Ingredients
    Ingredient Name Strength
    Propylene Glycol  
    Sodium Phosphate, Dibasic, Anhydrous  
    Sodium Lauryl Sulfate  
    Chlorocresol  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50405-110-01 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 11/15/2013
    Labeler - SOHM Inc. (009303848)
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