Label: DERMA PELLA INTIMATE BRIGHTENING- alpha arbutin cream

  • NDC Code(s): 82160-818-01
  • 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 22, 2023

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

  • Form and Presentation

    Cream: Plastic Tube, 40 g

  • Active Ingredient

    Alpha Arbutin

  • Inactive Ingredients

    Aqua, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Polyacrylamide, Phenoxyethanol, Glycerin, C13-14 Isoparaffin, Niacinamide (Vitamin B3), Glycyrrhiza Glabra (Licorice) Root Extract, Hyaluronic Acid, Laureth-7, Ethylhexylglycerin, Citric Acid, Parfum, Benzoic Acid, Dehydroacetic Acid.

  • Purpose

    Whitening Cream for Sensitive Area

  • Properties

    This product is formulated for use on all skin types and applicable to sensitive, intimate areas.

    - Lightens, protects and rejuvenate the skin.
    - Brings back the elasticity of the skin.
    - Moisture the delicate skin.
    - Soothes the skin in a pleasure way.
    - Leaves a long-lasting refreshing aroma.

    Paraben free

  • Indication

    Intimate area brightening cream for women and men.

  • Precautions

    Keep out of reach of children

  • Warnings

    - For external use only.
    - Over application will not increase results.
    - If you have a sensitive skin test in a small area in the underarm before using on all your intimate areas.
    - Discontinue if excessive redness or irritation occurs. If irritation persists, consult with a physician or pharmacist.
    - Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.
    - Do not apply to open wounds or mucous membranes.

  • Contraindications

    Hypersensitivity to any of the components.

  • Side effects

    It is well tolerated product there are no known side effects.

  • Dosage and Administration

    Cleanse area with soap and water, and then gently exfoliate it with a loofah or sponge. This helps to remove any dead skin at the surface and allow the product to contact the fresh area that you want to whiten. Rinse the area and pat dry. Apply a small amount to fingertips and massage gently into the desired area that you are whitening. Allow time for it to absorb. After a few minutes, massage any excess cream into the area. Only use enough cream to apply a thin layer. Apply twice daily for maximum effectiveness.

  • Storage Conditions

    Store below 30 C.

  • Primary Package

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    DERMA PELLA INTIMATE BRIGHTENING 
    alpha arbutin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-818
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALPHA-ARBUTIN (UNII: 72VUP07IT5) (ALPHA-ARBUTIN - UNII:72VUP07IT5) ALPHA-ARBUTIN10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    SQUALENE (UNII: 7QWM220FJH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-7 (UNII: Z95S6G8201)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-818-011 in 1 CARTON05/09/2023
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/09/2023
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)