NDC 36800-267

TopCare Calaclear

Pramoxine Hydrochloride And Zinc Acetate Lotion

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

Product ID36800-267_8dce8817-b906-4064-e053-2995a90a071e
NDC36800-267
Product TypeHuman Otc Drug
Proprietary NameTopCare Calaclear
Generic NamePramoxine Hydrochloride And Zinc Acetate 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 NamePRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active Ingredient Strength10 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-267-96

177 mL in 1 CONTAINER (36800-267-96)
Marketing Start Date2019-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-267-96 [36800026796]

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

Drug Details

Active Ingredients

IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL

NDC Crossover Matching brand name "TopCare Calaclear" or generic name "Pramoxine Hydrochloride And Zinc Acetate Lotion"

NDCBrand NameGeneric Name
36800-267TopCare Calaclearpramoxine hydrochloride and zinc acetate lotion
70000-0397Calamine ClearPramoxine Hydrochloride and Zinc Acetate Lotion
0536-1269Rugby Caldyphen Clearpramoxine hydrochloride and zinc acetate lotion
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.