Label: PORE RELEASE 2 SALICYLIC ACID ACNE TREATMENT- salicylic acid liquid

  • 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 December 2, 2022

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 2%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Reduces the number of blackheads
    • Helps keep skin clear of new black heads
  • 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. If contact occurs, flush thoroughly with water.

    Keep out of reach of children.

    If swallowed, get medical help or conact a Poison Control Center right away.

    Stop use and ask a doctor if

    • irritation becomes severe

    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.

  • Directions

    • Cleanse the skin thoroughly before applying this product. • Cover the entire affected area with a thin layer one to three times daily. • 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

  • Inactive ingredients

    water/aqua, butylene glycol, gluconolactone, arginine, glycolic acid, aloe barbadensis leaf juice, nelumbo nucifera root water, glycerin, hydrolyzed gardenia florida extract, biosaccharide gum-1, sodium levulinate, glyceryl caprylate, maltodextrin, sodium anisate, sodium hydroxide, potassium sorbate, sodium benzoate, citric acid

  • Questions or comments?

    347-669-0686

  • Package Labeling:

    Label0

    innerlabel

  • INGREDIENTS AND APPEARANCE
    PORE RELEASE 2 SALICYLIC ACID ACNE TREATMENT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73381-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ARGININE (UNII: 94ZLA3W45F)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73381-001-001 in 1 BOX12/01/202211/21/2024
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/202211/21/2024
    Labeler - Hero Cosmetics, Inc. (053668306)
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