NDC 41520-184

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 Foodhold Usa. The primary component is Zinc Oxide; Pramoxine Hydrochloride; Ferric Oxide Red.

Product ID41520-184_7cad7ad7-347b-6992-e053-2a91aa0a9ad6
NDC41520-184
Product TypeHuman Otc Drug
Proprietary NameCalamine Plus Pramoxine HCl
Generic NameCalamine Plus Spray
Dosage FormAerosol, Spray
Route of AdministrationTOPICAL
Marketing Start Date2019-02-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameFoodhold USA
Substance NameZINC OXIDE; PRAMOXINE HYDROCHLORIDE; FERRIC OXIDE RED
Active Ingredient Strength24 mg/116g; mg/116g; mg/116g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 41520-184-41

116 g in 1 CANISTER (41520-184-41)
Marketing Start Date2019-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41520-184-41 [41520018441]

Calamine Plus Pramoxine HCl AEROSOL, SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-01

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE24.16 mg/116g

OpenFDA Data

SPL SET ID:7cad7ad7-347a-6992-e053-2a91aa0a9ad6
Manufacturer
UNII
UPC Code
  • 0041520141156
  • 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

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