ACNEZZOL BASE- salicylic acid lotion 
SOLUTION INTERNATIONAL INC

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.

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acnezzol™
base

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 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 – Tube Label

Fast dual action
to clear skin

acnezzolbase

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
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)

Revised: 4/2013
Document Id: 7c7427a7-aa33-4103-b8d6-d79a6e70c58c
Set id: e625acc4-e861-424a-9dab-b30d2dd375ee
Version: 1
Effective Time: 20130418
 
SOLUTION INTERNATIONAL INC