Label: EPOCH- salicylic acid gel

  • 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 March 24, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid (2%)

  • Purpose

    Acne medication

  • Use

    For the treatment of acne.

  • Warnings

    • For external use only. Using other topical 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Cleanse skin thoroughly before applying.
    • Cover the affected area with a thin layer one to three times a day.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Inactive Ingredients

    Water (Aqua), PEG-32, PVM/MA Decadiene Crosspolymer, Coix Lacryma-Jobi Ma-yuen Seed Extract, Achillea Millefolium Extract, Arctium Lappa Root Extract, Butylene Glycol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Alpha-Glucan Oligosaccharide, Sodium Hydroxide, Disodium EDTA, Fragrance (Parfum).

  • Questions?

    1-888-742-7626

  • PRINCIPAL DISPLAY PANEL - 15 ml Tube Label

    epoch ®

    Acne Medication

    Blemish Treatment

    Epoch® Acne Medication Blemish Treatment helps diminish
    the discomfort of breakouts with unique ethnobotanicals—Job's tears,
    used historically in Asia to calm the skin; yarrow, used for centuries
    to help soothe the skin; burdock, which helps clear up troubled
    complexions; and skin-soothing chamomile extract. Also contains the
    proven pore-clearing acne medicine, salicylic acid. Naturally
    fragrance-free, the formula is friendly to sensitive skin.

    15 ml e (0.5 fl. oz.)

    Principal Display Panel - 15 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    EPOCH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62839-1084
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    Coix Lacryma-Jobi Var. Ma-Yuen Seed (UNII: 8DW238I7ZI)  
    Achillea Millefolium (UNII: 2FXJ6SW4PK)  
    Arctium Lappa Root (UNII: 597E9BI3Z3)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62839-1084-51 in 1 POUCH
    115 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/10/2001
    Labeler - NSE Products, Inc. (966817975)
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