Label: JACK BLACK BALANCING FOAM CLEANSER- salicylic acid gel

  • 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 November 3, 2022

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  • Active Ingredients

    Salicylic Acid 0.5%

    Purpose

    Acne Treatment

  • Uses

    • For the treatment of acne
    • Clears acne blemishes and blackheads.
    • Penetrates pores to control acne blemishes and blackheads.
    • Helps prevent new acne blemishes and blackheads from forming
  • 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 medication at a time.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Dispense 1-2 Pumps into hand, apply to damp or dry face, and massage into skin in a circular motion.   Rinse thoroughly with warm water and pat dry. Use morning and evening.

  • Inactive Ingredients

    Water, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Butylene Glycol, Glycerin, Propanediol, Lactic Acid, Phenoxyethanol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Ethylhexylglycerin, Bisabolol, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice.

  • PRINCIPAL DISPLAY PANEL

    FoamclnsUC

  • INGREDIENTS AND APPEARANCE
    JACK BLACK BALANCING FOAM CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66738-434-011 in 1 CARTON02/12/2021
    1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/12/2021
    Labeler - Jack Black LLC (847024036)
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