Label: OKAY FACIAL WASH- salicylic acid gel

  • NDC Code(s): 74553-015-01
  • Packager: Xtreme Tools International, Inc
  • 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 September 11, 2023

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  • Drug Facts

  • Active Ingredient

    Salicylic Acid (2%)

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

  • Warning

    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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    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 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), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, Acrylates Crosspolymer-4, Sodium Hydroxide, Carica Papaya Fruit Extract, Psidium Guajava (Guava) Fruit Extract, Panthenol, Fragrance

  • QUESTIONS

    Questions or comments?
    Call 1-305-622-7474 Mon-Fri 9 am-5 pm

  • PACKAGE LABEL

    NDC 74553-015-01

    Facial Wash

  • INGREDIENTS AND APPEARANCE
    OKAY FACIAL WASH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-015
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    Glycerin (UNII: PDC6A3C0OX)  
    ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PAPAYA (UNII: KU94FIY6JB)  
    GUAVA (UNII: 74O70D6VG0)  
    Panthenol (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-015-01118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/11/2023
    Labeler - Xtreme Tools International, Inc (125398904)
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