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Acnezzol Base (SOLUTION INTERNATIONAL INC)

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LOTION 29.5735 mL in 1 TUBE (58268-013-01) Label Information

Complete Acnezzol Base Information

  • Active ingredient:

    Salicylic acid 1.0%


  • Uses:

    For the treatment of acne.


  • 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 acnezzolâ„¢ 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 acnezzolâ„¢ activator after acnezzolâ„¢ 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

    acnezzolâ„¢ 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 Type HUMAN OTC DRUG Item Code (Source) NDC:58268-013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 1.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58268-013-01 29.5735 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/10/2013
    Labeler - SOLUTION INTERNATIONAL INC (062639742)
    Registrant - KANTIAN SKINCARE, LLC (078436984)
    Establishment
    Name Address ID/FEI Business Operations
    Kantian Skincare, LLC 078436984 LABEL(58268-013)
    Establishment
    Name Address ID/FEI Business Operations
    PhytogenX, Inc 010297942 MANUFACTURE(58268-013)