NDC 0536-1269

Rugby Caldyphen Clear

Pramoxine Hydrochloride And Zinc Acetate Lotion

Rugby Caldyphen Clear is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Pramoxine Hydrochloride; Zinc Acetate.

• Product ID: 0536-1269_9af3b16a-235f-d1b9-e053-2995a90ab0e7
• NDC: 0536-1269
• Product Type: Human Otc Drug
• Proprietary Name: Rugby Caldyphen Clear
• Generic Name: Pramoxine Hydrochloride And Zinc Acetate Lotion
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-12-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: Rugby Laboratories
• Substance Name: PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
• Active Ingredient Strength: 10 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0536-1269-58

177 mL in 1 CONTAINER (0536-1269-58)

• Marketing Start Date: 2019-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0536-1269-58 [00536126958]

Rugby Caldyphen Clear LOTION

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-12-30

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 9af3a740-ef97-26ce-e053-2a95a90a0ee1
• Manufacturer:
  • Rugby Laboratories
• UNII:
  • 88AYB867L5
  • FM5526K07A
• RxNorm Concept Unique ID - RxCUI:
  • 1234546

NDC Crossover Matching brand name "Rugby Caldyphen Clear" or generic name "Pramoxine Hydrochloride And Zinc Acetate Lotion"

NDC	Brand Name	Generic Name
0536-1269	Rugby Caldyphen Clear	pramoxine hydrochloride and zinc acetate lotion
70000-0397	Calamine Clear	Pramoxine Hydrochloride and Zinc Acetate Lotion
36800-267	TopCare Calaclear	pramoxine hydrochloride and zinc acetate lotion