NDC 11383-265

Freds Medicated anti itch

Pramoxine Hydrochloride, Menthol

Freds Medicated anti itch is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Weeks And Leo, Inc.. The primary component is Pramoxine Hydrochloride; Menthol.

Product ID11383-265_8697e70b-a9a0-8c9a-e053-2991aa0a9b8e
NDC11383-265
Product TypeHuman Otc Drug
Proprietary NameFreds Medicated anti itch
Generic NamePramoxine Hydrochloride, Menthol
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2014-04-13
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameWeeks and Leo, Inc.
Substance NamePRAMOXINE HYDROCHLORIDE; MENTHOL
Active Ingredient Strength1 g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11383-265-51

1 TUBE in 1 CARTON (11383-265-51) > 28 g in 1 TUBE
Marketing Start Date2014-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11383-265-51 [11383026551]

Freds Medicated anti itch CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-13

NDC 11383-265-01 [11383026501]

Freds Medicated anti itch CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-13

Drug Details

Active Ingredients

IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g

OpenFDA Data

SPL SET ID:86986d05-8830-0853-e053-2a91aa0a4b14
Manufacturer
UNII

NDC Crossover Matching brand name "Freds Medicated anti itch" or generic name "Pramoxine Hydrochloride, Menthol"

NDCBrand NameGeneric Name
11383-265Freds Medicated anti itchPramoxine hydrochloride, menthol
53943-265Freds Medicated anti itchPramoxine hydrochloride, menthol
55315-265Freds Medicated anti itchPramoxine hydrochloride, menthol
63941-265Best Choice Medicated anti itchPramoxine hydrochloride, menthol
69842-265CVS Medicated anti itchPramoxine hydrochloride, menthol
41167-0507Gold Bond Intensive Relief Anti-ItchPramoxine Hydrochloride, Menthol
63868-959QC Medicated anti itchPramoxine hydrochloride, menthol

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