Label: ACNEZZOL BASE- salicylic acid lotion

  • 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 April 18, 2013

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  • Active ingredient:

    Salicylic acid 1.0%

  • Uses:

    For the treatment of acne.

  • PURPOSE

  • Warnings:

    For external use only. Avoid contact with eyes. If contact occurs, flush thoroughly with water. This product may cause irritation. If excess irritation occurs, discontinue use. Avoid unnecessary sun exposure and use sunscreen. Allow acnezzol™ base to dry, then follow the sunscreen directions. Do not use this product if you have sensitive skin or If you are sensitive to AH As.

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

  • Directions:

    Apply a thin layer to affected area only, In the morning and evening. For best results, apply acnezzol™ activator after acnezzol™ base. Wash hands thoroughly after application.

  • Inactive Ingredients:

    Water, Isopropyl alcohol, Propylene glycol, Hydroxyethylcellulose, Mandelic acid, Methyloxirane, Oxirane, Sodium benzoate, FD&C Blue #1.

    Dist. by: SOLUTION INTERNATIONAL, INC.

    Miami Beach, FL 33140 Made in USA ©2012

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    Fast dual action
    to clear skin

    acnezzol™ base

    Eliminates acne causing bacteria

    Clinical results without a prescription

    Gentle enough for everyday use

    Dermatologist Recommended
    FDA REGISTERED
    MADE IN USA
    NET WT. 1 OZ. (28 G)

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    ACNEZZOL BASE 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58268-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Mandelic Acid (UNII: NH496X0UJX)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Propylene Oxide (UNII: Y4Y7NYD4BK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58268-013-01 29.5735 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/10/2013
    Labeler - SOLUTION INTERNATIONAL INC (062639742)
    Registrant - KANTIAN SKINCARE, LLC (078436984)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kantian Skincare, LLC078436984LABEL(58268-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc010297942MANUFACTURE(58268-013)
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