NDC 0496-0741

PRAX

Pramoxine Hydrochloride 1%

PRAX is a Topical Cloth in the Human Otc Drug category. It is labeled and distributed by Ferndale Laboratories, Inc.. The primary component is Pramoxine Hydrochloride.

• Product ID: 0496-0741_2b08d90e-47e9-7023-e054-00144ff8d46c
• NDC: 0496-0741
• Product Type: Human Otc Drug
• Proprietary Name: PRAX
• Generic Name: Pramoxine Hydrochloride 1%
• Dosage Form: Cloth
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-02-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: Ferndale Laboratories, Inc.
• Substance Name: PRAMOXINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0496-0741-65

12 POUCH in 1 CARTON (0496-0741-65) > 6 g in 1 POUCH (0496-0741-76)

• Marketing Start Date: 2016-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0496-0741-76 [00496074176]

PRAX CLOTH

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-01
• Marketing End Date: 2018-02-28

NDC 0496-0741-65 [00496074165]

PRAX CLOTH

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-02-01
• Marketing End Date: 2018-02-28

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/g

OpenFDA Data

• SPL SET ID: 2b08cf96-0ddf-5179-e054-00144ff88e88
• Manufacturer:
  • Ferndale Laboratories, Inc.
• UNII:
  • 88AYB867L5
• RxNorm Concept Unique ID - RxCUI:
  • 1039541
  • 1246070

NDC Crossover Matching brand name "PRAX" or generic name "Pramoxine Hydrochloride 1%"

NDC	Brand Name	Generic Name
0496-0741	PRAX	pramoxine hydrochloride 1%
0496-0748	PRAX	pramoxine hydrochloride
50268-682	PRAX	pramoxine hydrochloride