NDC 41250-235

Calamine Plus Pramoxine HCL

Calamine Plus Spray

Calamine Plus Pramoxine HCL is a Topical Aerosol, Spray in the Human Otc Drug category. It is labeled and distributed by Meijer Distribution Inc.. The primary component is Ferric Oxide Red; Pramoxine Hydrochloride; Zinc Oxide.

Product ID41250-235_902d34b9-6a38-4de7-e053-2a95a90a0a7b
NDC41250-235
Product TypeHuman Otc Drug
Proprietary NameCalamine Plus Pramoxine HCL
Generic NameCalamine Plus Spray
Dosage FormAerosol, Spray
Route of AdministrationTOPICAL
Marketing Start Date2020-03-14
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameMeijer Distribution Inc.
Substance NameFERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active Ingredient Strength0 mg/116g; mg/116g; mg/116g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 41250-235-41

116 g in 1 CANISTER (41250-235-41)
Marketing Start Date2020-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41250-235-41 [41250023541]

Calamine Plus Pramoxine HCL AEROSOL, SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-14

Drug Details

Active Ingredients

IngredientStrength
FERRIC OXIDE RED.345 mg/116g

OpenFDA Data

SPL SET ID:902d34b9-6a37-4de7-e053-2a95a90a0a7b
Manufacturer
UNII

NDC Crossover Matching brand name "Calamine Plus Pramoxine HCL" or generic name "Calamine Plus Spray"

NDCBrand NameGeneric Name
0363-8588Calamine Plus Pramoxine HClCalamine Plus No-Touch
11673-635Calamine Plus Pramoxine HClCalamine Plus Spray
30142-156Calamine Plus Pramoxine HClCalamine Plus Spray
36800-398Calamine Plus Pramoxine HClCalamine Plus Spray
41250-235Calamine Plus Pramoxine HCLCalamine Plus Spray
41520-184Calamine Plus Pramoxine HClCalamine Plus Spray
42507-147Calamine Plus Pramoxine HClCalamine Plus Spray
56104-031Calamine Plus Pramoxine HClCalamine Plus No Touch Spray
56104-251Calamine Plus Pramoxine HClCalamine Plus Spray
59779-174Calamine Plus Pramoxine HClCalamine Plus Spray
46122-745Calamine PlusCalamine Plus Pramoxine HCl

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.