Label: PHARMASKINCARE ACNECARE EXFOLIATOR- salicylic acid solution

  • 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 October 11, 2017

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

  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Warnings

    Warnings

    • For external use only.
    • When using this product : skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Directions

    Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer and rinse thoroughly 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.

    Massage Acnecare Exfoliator onto cleansed, damp skin with fingertips using a circular motion. Rinse well with lukewarm water and pat dry. Avoid use on flare-ups and breakouts.

  • Uses:

    For the treatment of acne.

  • Inactive Ingredients:

    Water, Phytelephas Aequatorialis Seed Powder, Glycerin, Glyceryl Stearate SE, Cocamidopropyl Betaine, Carthamus Tinctorius (Safflower) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Hydroxyethylcellulose, *CO Glycerin, *CO Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Papain, *CO Aesculus Hippocastanum (Horse Chestnut) Seed Extract, *CO Prunus Armeniaca (Apricot) Fruit Extract, *CO Rosa Centifolia Flower Extract, *CO Rosmarinus Officinalis (Rosemary) Leaf Extract, **Squalane, DMAE, Thioctic Acid, Ubiquinone, Carica Papaya (Papaya) Fruit Extract, Sea Salt (Dead Sea Salt), Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Lecithin, Glycolic Acid, Tartaric Acid, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Fragrance, Dehydroacetic Acid

  • Warning

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    Pharmaskincare AcnecareExfoliator.jpg

    Pharmaskincare AcnecareExfoliator.jpg

  • INGREDIENTS AND APPEARANCE
    PHARMASKINCARE ACNECARE EXFOLIATOR 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.013 mg  in 2.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PHYTELEPHAS AEQUATORIALIS SEED (UNII: 2DJN5A6ONH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-9110-1120 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/10/2017
    Labeler - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-9110)