NDC 53329-165

REMEDY Calazime Skin Protectant

Calamine, Menthol, White Petrolatum, Zinc Oxide

REMEDY Calazime Skin Protectant is a Topical Paste in the Human Otc Drug category. It is labeled and distributed by Medline Industries, Inc.. The primary component is Ferric Oxide Red; Menthol; Petrolatum; Zinc Oxide.

Product ID53329-165_66d9c437-652e-433a-e053-2991aa0ab0e2
NDC53329-165
Product TypeHuman Otc Drug
Proprietary NameREMEDY Calazime Skin Protectant
Generic NameCalamine, Menthol, White Petrolatum, Zinc Oxide
Dosage FormPaste
Route of AdministrationTOPICAL
Marketing Start Date2012-03-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameMedline Industries, Inc.
Substance NameFERRIC OXIDE RED; MENTHOL; PETROLATUM; ZINC OXIDE
Active Ingredient Strength1 g/100g; g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53329-165-44

113 g in 1 TUBE (53329-165-44)
Marketing Start Date2018-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53329-165-96 [53329016596]

REMEDY Calazime Skin Protectant PASTE
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-14

NDC 53329-165-44 [53329016544]

REMEDY Calazime Skin Protectant PASTE
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2018-03-14

Drug Details

Active Ingredients

IngredientStrength
FERRIC OXIDE RED.5 g/100g

OpenFDA Data

SPL SET ID:1295cfcc-5b61-481b-964b-f53ffd0cb58e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1921772
  • 1921775

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