Label: ACNECARE DERMACONTROL CREAM- 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 December 23, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Benzoyl Peroxide (5%)..........Acne Treatment

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    For treatment of acne

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    When using this product

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

  • DOSAGE & ADMINISTRATION

    Directions:

    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. . If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and consult a doctor.

    Sensitivity test for a new user: Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions as stated.

  • INACTIVE INGREDIENT

    Other Ingredients:

    Aqua, Caprylic/Capric Triglyceride, Cetyl Alcohol, Ethoxydiglycol, Polyglyceryl-6 Distearate, Stearic Acid, Dimethicone, Jojoba Esters, Carbomer, Lactic Acid, Glycolic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Polyglyceryl-3 Beeswax, Sodium PCA, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, BHT, Titanium Dioxide, *CO Glycerin, Glycerin, Citric Acid, Malic Acid, DMAE, Ubiquinone, Thioctic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Salicylic Acid, Tartaric Acid, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid. *Certified Organic

  • PRINCIPAL DISPLAY PANEL

    acnecaredermacontrol.jpg

  • INGREDIENTS AND APPEARANCE
    ACNECARE DERMACONTROL CREAM 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE3 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    ETHOXYDIGLYCOL OLEATE (UNII: 843B4EZH9X)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-8090-160 mL in 1 TUBE; Type 0: Not a Combination Product12/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00612/23/2022
    Labeler - Spa de Soleil (874682867)
    Registrant - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-8090)