Label: DERMA PELLA ACNE WASH FOR OILY SKIN- salicylic acid solution

  • NDC Code(s): 82160-764-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • 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 June 18, 2023

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

View All Sections
  • Forms and Presentation

    Solution: Plastic Bottle, 150 ml

  • Active Ingredient

    Salicylic Acid

  • Inactive Ingredients

    Aqua, Glycerin, Cocamidopropyl Betain, Sodium C14-16 Olefin Sulfonate, Butylene Glycol, Polysorbate 20, Sodium Benzoate, Allantoin, Potassium Sorbate, Disodium EDTA, Parfum, Citric Acid, 2-Bromo-2-Nitropropane-1,3-Diol, Tetrasodium EDTA, Bacillus Ferment

  • Purpose

    Facial Cleanser for Oily Skin

  • Properties

    A lightweight, translucent, water-based Alcohol and Sulfate free facial foaming cleanser.

    This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that helps remove dead skin cells, reduce blackheads and the appearance of pores, so it prevents acne.

    And also it contains Bacillus Ferment which is a multifunctional biotechnological ingredient obtains from microorganism isolated from natural clay, offers a cleaner smother and more beautiful skin by:

    - P. acne biofilm inhibition.
    - Reduced inflammatory response to P. acne.
    - Skin regenerating effect.
    - Cleansing activity.
    - Antioxidant response determined by reactive oxygen species (ROS).

    Also it contains 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

    Non-irritating foaming cleanser formulated for acne-prone skins, helps gently exfoliate skin without over drying, deep cleans pores control excess oil, unclog pores and prevent new acne from forming.

  • Precautions

    Keep out of reach of children

  • Warnings

    - For external use only.
    - Discontinue if excessive skin irritation develops or increases. If irritation persists, consult with a physician or pharmacist.
    - 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 but mild irritation, dryness, redness may occur.

  • 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 non comedogenic moisturizer.
    - If excessive dryness or peeling occurs, reduce usage.

  • Storage Conditions

    Store below 30 ◦C.

  • PRINCIPAL DISPLAY PANEL

    Primary Package

  • INGREDIENTS AND APPEARANCE
    DERMA PELLA ACNE WASH FOR OILY SKIN 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-764
    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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-764-01150 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
    OTC monograph finalM00605/16/2023
    Labeler - Pella Pharmaceuticals Co. Ltd (562370925)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!