Label: DERMACLEANSE- salicylic acid gel

  • NDC Code(s): 83313-0004-6
  • Packager: ZENMED Raging Creations Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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  • ACTIVE INGREDIENT

    SALICYLIC ACID 2.0%

  • PURPOSE

    ACNE TREATMENT GEL.

  • INDICATIONS

    FOR THE TREATMENT OF ACNE. REDUCES SEVERITY OF ACNE BLEMISHES. ALLOWS SKIN TO HEAL. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

  • DIRECTIONS

    CLENSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONCE DAILY BEFORE BED. 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.

  • WARNINGS

    FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR. ASK A DOCTOR OR PHARMACIST BEFORE USE ON CHILDREN. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH CARE PROFESSIONAL BEFORE USE.

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENTS

    PURIFIED WATER, WITCH HAZEL DISTILLATE, VEGETABLE GLYCERIN, HYDROXYETHYLCELLULOSE, SODIUM GLYCOLATE, SPIRAEA ULMARIA EXTRACT, VITAMIN B5, METHYLISOTHIAZOLINONE, CHLORHEXIDINE GLUCONATE.

  • PRINCIPAL DISPLAY PANEL - 30 ml Tube Label

    DERMACLEANSE™
    ACNE GEL

    Rapid Acne
    Clearing Formula

    Formulated with BHA,
    Meadowsweet Extract,
    & Glycolic Acid

    VEGAN,
    PLANT-BASED

    CRUELTY-FREE
    CERTIFIED

    30 ml | 1 fl oz

    ZENMED®

    Reconstructive Skincare

    PRINCIPAL DISPLAY PANEL - 30 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    DERMACLEANSE 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83313-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SODIUM GLYCOLATE (UNII: B75E535IMI)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83313-0004-630 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00604/01/2023
    Labeler - ZENMED Raging Creations Ltd. (203762150)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Deep Inc.189788201MANUFACTURE(83313-0004)
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