Label: CRYSTAL CLEAR ACNE TREATMENT PADS- salicylic acid patch

  • 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 March 21, 2023

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

  • Drug Facts

  • Active ingredient

    Salicylic acid 2% w/v

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

    When using this product • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • avoid contact with eyes, lips and mouth. If contact occurs, flush thoroughly with water.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the skin thoroughly before applying this product • cover the entire affected area one to two times daily, avoiding eye area • allow to absorb before applying additional products • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 • do not rinse • tighten cap after use to prevent pads from drying out.
    Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions stated above.

  • Other information

    • store at 68° - 77° F • protect from excessive moisture
    • Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.

  • Inactive ingredients

    Allantoin, Aloe (Aloe barbadensis) leaf extract, Beta-glucan, Caprylic/capric triglyceride, Chamomile (Chamomilla recutita) flower extract, Cucumber (Cucumis sativus) fruit extract, Dipotassium glycyrrhizate, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Glycolic acid, Grapefruit (Citrus grandis) peel extract, Lactic acid, Licorice (Glycyrrhiza glabra) root extract, Menthyl lactate, PEG-40 hydrogenated castor oil, Phenoxyethanol, PPG-26-Buteth-26, Sodium hydroxide, Tetrasodium EDTA, Water (Aqua), White mulberry (Morus alba) root extract

  • Questions?

    +1-615-582-6726
    You may also report serious side effects to this phone number.

    Mon - Fri, 9:30 AM - 5:30 PM

  • SPL UNCLASSIFIED SECTION

    Manufactured for Skin Pharm, Nashville, TN 37212

    skinpharm.com

  • Packaging

    Acnepad001

  • INGREDIENTS AND APPEARANCE
    CRYSTAL CLEAR ACNE TREATMENT PADS 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83316-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83316-001-0160 in 1 JAR02/16/2023
    11.2 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00602/16/2023
    Labeler - Skin Pharm, LLC (040717587)