ACNEZZOL BASE- salicylic acid lotion

Acnezzol Base by

Drug Labeling and Warnings

Acnezzol Base by is a Otc medication manufactured, distributed, or labeled by SOLUTION INTERNATIONAL INC, KANTIAN SKINCARE, LLC, Kantian Skincare, LLC, PhytogenX, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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)