Label: DERMA PELLA CLEANSER FOR SENSITIVE AND DRY SKIN- niacinamide solution

  • NDC Code(s): 82160-771-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 19, 2023

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  • Form and Presentation

    Solution: Plastic Bottle, 150 ml

  • Active Ingredient

    Niacinamide (Vitamin B3)

  • Inactive Ingredients

    Aqua, Glycerin, Cocamidopropyl Betain, Sodium C14-16 Olefin Sulfonate, Butylene Glycol, Polysorbate 20, Sodium Benzoate, Allantoin, Potassium Sorbate, Disodium EDTA, Cucumis Sativus (Cucumber) Fruit Extract, Parfum, Aloe Barbadensis (Aloe Vera) Leaf Extract, Citric Acid, Phenoxyethanol, 2-Bromo-2-Nitropropane-1,3-Diol, Tetrasodium EDTA, Benzoic Acid, Dehydroacetic Acid.

  • Purpose

    Facial Cleanser for Sensitive and Dry Skin

  • Properties

    A refreshing cleanser for sensitive and dry skin. It cleanses gently without a harsh drying effect, leaving your skin feeling refreshed. A combination of Aloe Vera, Cucumber Extracts, Vitamin B3 and Allantoin make it perfect for daily use.

    Aloe Vera Extract soothes irritated skin, increase skin hydration, fights bacteria and shields skin from pollutants and free radicals.

    Cucumber Extract is a good skin rejuvenator, cools, refreshes tones and firms skin for clean and fresh feeling and improving skin elasticity.

    Niacinamide (Vitamin B3) helps soothe and balance the appearance of skin tone.

    Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities.

    Paraben free, Alcohol free, SLS free, SLES free.

  • Indications

    A mild facial cleanser for sensitive and dry skin.

  • Precautions

    Keep out of reach of children

  • Warnings

    - For external use only.
    - Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.

  • Contraindications

    Hypersensitivity to any of the components.

  • Side Effects

    It is well tolerated product there is no known side effect.

  • Dosage and Administration

    - Use it twice a day, morning and night.
    - Pump 2 - 3 times onto the tips of your fingers.
    - Massage gently over wet skin in a circular motion for 1 min, avoiding eye area.
    - Rinse thoroughly, pat skin dry.
    - Follow with a moisturizer.

  • Storage Conditions

    Store below 30 C

  • PRINCIPAL DISPLAY PANEL

    Primary Package

  • INGREDIENTS AND APPEARANCE
    DERMA PELLA CLEANSER FOR SENSITIVE AND DRY SKIN 
    niacinamide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CUCUMBER (UNII: YY7C30VXJT)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-771-01150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/16/2023
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)