Label: DERMA PELLA ACNE CARE- salicylic acid gel

  • NDC Code(s): 82160-795-01
  • Packager: Pella Pharmaceuticals Co. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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

View All Sections
  • Form and Presentation

    Gel: Plastic Tube, 25 g

  • Active Ingredient

    Salicylic Acid

  • Inactive Ingredients

    Aqua, Glycerin, Ethoxydiglycol, Polyacrylamide, Ammonium Acryloyldimethyltaurate/VP Copolymer, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), C 13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Allantoin, Laureth-7, Disodium EDTA, Ethylhexylglycerin.

  • Purpose

    Acne care gel

  • Properties

    A lightweight, water-based alcohol-free gel.
    This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that clears out clogged pores, reduces blemishes, and helps to minimize blackheads and breakouts. It dissolves excess sebum, making it suitable for acne-prone skin.
    And also, it contains Tea tree oil which has soothing properties and improves the appearance of marks.
    In addition to Niacinamide (Vitamin B3) which works best to soothe and lighten skin, visibly minimize pores, and improve uneven skin tone, reduce dark spots and acne spots.
    It contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities.
    Paraben free, Alcohol free, Fragrance free.

  • Indications

    Helps to clear acne and reduce formation of new blackheads and whiteheads.

  • 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

    Skin irritations, dryness, redness more likely to occur when using another topical acne product at the same time, if irritation occurs, use only one product at a time.

  • Dosage and Administration

    - Cleanse skin thoroughly before applying product.
    - Dry your face and then apply a thin layer one to three times daily.
    - Because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily, if needed.
    - If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • Storage Conditions

    Store below 30 ◦C.

  • Primary Package

    Primary Package

  • Secondary Package

    Secondary Package

  • INGREDIENTS AND APPEARANCE
    DERMA PELLA ACNE CARE 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-795
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID18 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82160-795-011 in 1 CARTON03/30/2023
    125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/30/2023
    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!