Label: ACTIVE CLEAR FACIAL WASH- 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 June 24, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne treatment

  • Indications

    For treatment of acne

  • Warnings

    For external use only

    When using this product

    • Avoid contact with the eyes. If product gets into eyes, rinse thoroughly with water.
    • Using other topical acne medications 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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • Directions

    Apply cleanser on wet facial skin, gently massaging in circular motions until a creamy lather forms. Avoid the eye area. Rinse well with lukewarm water. For best results, use twice daily.

  • Inactive ingredients

    water/aqua, sodium cocoyl isethionate, cetearyl alcohol, stearic acid, glycerin, laureth-3, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, fragrance/parfum, disodium EDTA, maris sal (dead sea mineral water), caramel, butylphenyl methylpropional, hexyl cinnamal, linalool

  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

    SEACRET™
    MINERALS FROM THE DEAD SEA

    clear

    ACTIVE CLEAR
    FACIAL WASH
    For oily, acne-prone skin

    2%
    SALICYLIC
    ACID

    3.4 fl.oz / 100 mL

    PPRINCIPAL DISPLAY PANEL - 100 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    ACTIVE CLEAR FACIAL WASH 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69915-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Cocoyl Isethionate (UNII: 518XTE8493)  
    Cetostearyl alcohol (UNII: 2DMT128M1S)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Laureth-3 (UNII: F32E4CB0UJ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Caramel (UNII: T9D99G2B1R)  
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69915-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/12/2015
    Labeler - Seacret Spa LLC (363790846)
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