NDC 70000-0397

Calamine Clear

Pramoxine Hydrochloride And Zinc Acetate Lotion

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

• Product ID: 70000-0397_7f733c0a-82b3-d3b0-e053-2991aa0a6b0f
• NDC: 70000-0397
• Product Type: Human Otc Drug
• Proprietary Name: Calamine Clear
• Generic Name: Pramoxine Hydrochloride And Zinc Acetate Lotion
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-01-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: Cardinal Health
• 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 70000-0397-1

177 mL in 1 BOTTLE, PLASTIC (70000-0397-1)

• Marketing Start Date: 2019-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70000-0397-1 [70000039701]

Calamine Clear LOTION

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-01-15

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f
• Manufacturer:
  • Cardinal Health
• UNII:
  • 88AYB867L5
  • FM5526K07A
• RxNorm Concept Unique ID - RxCUI:
  • 1234546
• UPC Code:
  • 0096295135091

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

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