NDC 69492-012

KLEARACTIL

Acne Topical Treatment

KLEARACTIL is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Polimeros Y Servicios S.a.. The primary component is Salicylic Acid.

• Product ID: 69492-012_b869e975-c1b7-4a2a-9668-21db20366cf9
• NDC: 69492-012
• Product Type: Human Otc Drug
• Proprietary Name: KLEARACTIL
• Generic Name: Acne Topical Treatment
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-06-29
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part333D
• Labeler Name: POLIMEROS Y SERVICIOS S.A.
• Substance Name: SALICYLIC ACID
• Active Ingredient Strength: 5 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69492-012-20

1 TUBE in 1 BOX (69492-012-20) > 30 g in 1 TUBE (69492-012-05)

• Marketing Start Date: 2019-03-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69492-012-20 [69492001220]

KLEARACTIL GEL

• Marketing Category: OTC monograph final
• Application Number: part333D
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-03-04

NDC 69492-012-05 [69492001205]

KLEARACTIL GEL

• Marketing Category: OTC monograph final
• Application Number: part333D
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-06-29

Drug Details

Active Ingredients

Ingredient	Strength
SALICYLIC ACID	5 mg/g

OpenFDA Data

• SPL SET ID: 344381e7-dd11-4cb9-ad44-7a4176345aef
• Manufacturer:
  • POLIMEROS Y SERVICIOS S.A.
• UNII:
  • O414PZ4LPZ
• RxNorm Concept Unique ID - RxCUI:
  • 252296