NDC 0225-0516

ITCH-X

Pramoxine Hcl/benzyl Alcohol

ITCH-X is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Bf Ascher And Co Inc. The primary component is Pramoxine Hydrochloride; Benzyl Alcohol.

• Product ID: 0225-0516_3fb1e4d3-8e24-2227-e054-00144ff8d46c
• NDC: 0225-0516
• Product Type: Human Otc Drug
• Proprietary Name: ITCH-X
• Generic Name: Pramoxine Hcl/benzyl Alcohol
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-09-19
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: BF ASCHER AND CO INC
• Substance Name: PRAMOXINE HYDROCHLORIDE; BENZYL ALCOHOL
• Active Ingredient Strength: 1 g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0225-0516-51

59.1 mL in 1 BOTTLE, SPRAY (0225-0516-51)

• Marketing Start Date: 2014-09-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0225-0516-51 [00225051651]

ITCH-X SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-09-19

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	1 g/100mL

OpenFDA Data

• SPL SET ID: 03f85dbb-a13a-3126-e054-00144ff8d46c
• Manufacturer:
  • BF ASCHER AND CO INC
• UNII:
  • 88AYB867L5
  • LKG8494WBH
• RxNorm Concept Unique ID - RxCUI:
  • 1293637
  • 1293635