Label: EPIELLE EXFOLIATING SCRUB EXFOLIATING SCRUB- salicylic acid cream

  • 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 5, 2020

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  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Use

    penetrates pores to control acne blemishes and blackheads

  • WARNINGS

    Warnings For external use only. Using other topical acne medication at the same time or immediately following 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.

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet face
    • squeeze product into hands
    • massage over entire face
    • rinse thoroughly
    • for optimal results use 2-3 times per week
  • STORAGE AND HANDLING

    Other information

    store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium cocoyl isethionate, glycerin, synthetic wax, glycol disearate, synthetic wax, stearyl alcohol, docamide MEA, PEG-6 caprylic/capric glycerides, sodium hydroxide, acrylates/c 10-30 alkyl acrylate crosspolymer, stearic acid, sodium benzoate, menthol, santhan gum, lavandula angustifolia(lavender) extract, salvia sclarea (clary) extract, hyacinthus orientalis (hyacinth) extract, chamomilla recutita (matricaria) flower/leaf extract, borago officinalis (borage) extract, centaurea cyanus (cornflower) flower extract, butylene glycol, 1,2-hexanediol, ethylhexylglyerin, blue 1 lake, fragrance

  • PRINCIPAL DISPLAY PANEL

    Epielle exfoliating scrub

    tube

  • INGREDIENTS AND APPEARANCE
    EPIELLE EXFOLIATING SCRUB  EXFOLIATING SCRUB
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.8 g  in 141 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    COCAMIDE (UNII: 3YXD33R71G)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0403-5141 g in 1 TUBE; Type 0: Not a Combination Product05/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/31/2018
    Labeler - Kareway Product, Inc. (121840057)
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