Label: ENFUSELLE ACNE CLARIFYING- salicylic acid lotion

  • 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 December 13, 2022

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

  • Drug Facts


  • Active Ingredient

    Salicylic Acid (0.5%)

  • Purpose

    Acne treatment

  • Uses

    For the treatment of acne.

  • Warnings

    • For external use only.
  • When using this product

    • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only  one topical acne medication at a time.
    • Keep out of eyes. Rinse with water to remove.
  • Keep out of reach of children.

    In swallowed, get medical help or contact a Poison Control Center right away.

  • Directions for Use

    • Clean the skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer one to three times daily.
    • 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/Eau, SD Alcohol 40-B, Cyclodextrin, Polysorbate 20, Xanthan Gum, 4-Terpineol*, Triethanolamine, Galactoarabinan, Zinc Gluconate, Sodium Coco PG-Dimonium Chloride Phosphate, Leptospermum Scoparium Branch/Leaf Oil, Tocopheryl Acetate, Dipostassium Glycyrrhizate, Panthenol, Disodium EDTA, Cetearyl Ethylhexanoate, Butylene Glycol, Nasturtium Officinale Extract, Arctium Lappa Root Extract, Aloe Barbadensis Leaf Juice, Pyridoxine HCL, Retinyl Palmitate.

  • Principal Labeling

    PARABEN FREE

    salicylic acid
    acne treatment

    1fl. oz. 29mL
    120applications

    All Skin Types


    This exclusive treatment formula gently and comprehensively controls the factors that contribute to the cycle of acne-troubled skin.
    Features an exclusive blend of nourishing antioxidants and purifying botanicals to help normalize sebum, unclog pores, speed healing, and reduce
    redness caused by acne. With continued use, skin will become visibly smoother, clearer, and shine free.

    • Not tested on animals
    • 100% free of
      occlusive oils

    Shaklee
    Dist. by/par
    Shaklee Corporation
    4747 Willow Road
    Pleasanton, CA 94588 USA
    Item #39075

    • Breakthrough patented
    formula
    • Contains botanical
    extracts:
    - tea tree (Melaleuca
    alternifolia) oil
    - manuka
    (Leptospermum
    scoparium) oil
    - licorice (Dipotassium
    glycyrrhizate) extract
    - burdock (Arctium
    lappa) root extract
    - watercress (Nasturtium
    officinale) extract
    - aloe vera (Aloe
    barbadensis) leaf juice
    • Features antioxidant
    vitamins A and E
    • Gentle enough to use
    daily for maximum
    acne control
    • 100% fragrance and
    paraben free
    • Allergy tested
    • Clinically formulated
    • Dermatologist tested


    Do not store at
    temperatures above 10O°F.
    U.S. Palent: 6,403,110

    Apply this exclusive facial formula to help keep skin blemish free, speed healing and reduce redness caused by acne. Gentle enough to use daily, this unique blend of botanicals and nourishing antioxidants effectively controls the factors that contribute to the cycle of acnetroubled
    skin.


    WARNINGS: For external use only. Keep out of eyes. “Keep out of reach of children. If excessive dryness or peeling occurs, reduce the application to once a day or every other day.

    Directions: Apply one to three times daily after cleansing and toning. Allow to dry after application. Follow with the Enfuselle treatment or moisturizer for your skin type.

  • Package Labeling:

    1

  • INGREDIENTS AND APPEARANCE
    ENFUSELLE ACNE CLARIFYING 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59899-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59899-002-011 in 1 CARTON08/08/2013
    129 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/08/2013
    Labeler - Shaklee Corporation (129469263)