NDC 36800-268

TopCare Calagesic

Calamine And Pramoxine Hydrochloride Lotion

TopCare Calagesic is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Zinc Oxide; Pramoxine Hydrochloride.

Product ID36800-268_8dced3ea-147c-3d46-e053-2a95a90aa1c0
NDC36800-268
Product TypeHuman Otc Drug
Proprietary NameTopCare Calagesic
Generic NameCalamine And Pramoxine Hydrochloride Lotion
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2019-07-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameTOPCO ASSOCIATES LLC
Substance NameZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength80 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-268-96

177 mL in 1 CONTAINER (36800-268-96)
Marketing Start Date2019-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-268-96 [36800026896]

TopCare Calagesic LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-16

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE80 mg/mL

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