Klearactil (Acne Topical Treatment) Gel [Polimeros Y Servicios S.a.] -

KLEARACTIL (ACNE TOPICAL TREATMENT) GEL [POLIMEROS Y SERVICIOS S.A.]
PDF | XML

View All Sections

Detail showing Active Ingredient from package

Active ibgredients_001.jpg

Information shown both on container label and paclage
Detail showing Inactive ingredient from package

Inactive ingredients.jpg

Information shown both on container label and paclage
Detail showing Purpose within Active Ingredients from package

Purpose.jpg

Information shown both on container label and package
Detail showing Instructions for use and named Directions from package

indications_001.jpg

Information shown both on container label and package
Detail showing Dosage and Administration within Directions from package

Dosage and administration.jpg

Information shown both on container lable and package
Detail showing Warnings from package

Warnings.jpg

nformation shown both on container label and package
Detail showing Keep Out of Reach of Children within Warnings from package

Keep out of reach of Childreb.jpg

Information shown on package
Detail showing Questions from package

Questions.jpg

Information shown both on container label and package
etail showing Other Safety Information from package

Other safety information.jpg

nformation shown both on container label and package
Representative sample image of carton/container label

Container label.jpg

General view of inner container label

Package label.jpg

General view of box content of labeling

INGREDIENTS AND APPEARANCE

KLEARACTIL
acne topical treatment gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, L- (UNII: F9S9FFU82N)
METHYLPARABEN (UNII: A2I8C7HI9T)
ORTHOSILICIC ACID (UNII: 623B93YABH)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69492-012-20	1 in 1 BOX	03/04/2019
1	NDC:69492-012-05	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	06/29/2015

Labeler - POLIMEROS Y SERVICIOS S.A. (815740251)

Name	Address	ID/FEI	Business Operations
Establishment
POLIMEROS Y SERVICIOS S.A.		815740251	manufacture(69492-012)

View All Sections

Medic