NDC 0395-9109

Calamine Phenolated Topical Suspension

Calamine And Zinc Oxide And Phenol

Calamine Phenolated Topical Suspension is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Humco Holding Group, Inc.. The primary component is Zinc Oxide; Phenol.

Product ID0395-9109_99c4ef45-707e-f85f-e053-2995a90aae53
NDC0395-9109
Product TypeHuman Otc Drug
Proprietary NameCalamine Phenolated Topical Suspension
Generic NameCalamine And Zinc Oxide And Phenol
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2008-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameHumco Holding Group, Inc.
Substance NameZINC OXIDE; PHENOL
Active Ingredient Strength160 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0395-9109-96

177 mL in 1 BOTTLE, PLASTIC (0395-9109-96)
Marketing Start Date2017-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0395-9109-96 [00395910996]

Calamine Phenolated Topical Suspension LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-16

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE160 mg/mL

NDC Crossover Matching brand name "Calamine Phenolated Topical Suspension" or generic name "Calamine And Zinc Oxide And Phenol"

NDCBrand NameGeneric Name
0395-0407Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
0395-9109Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
24385-407Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
82645-921Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
49348-802Sunmark Phenolated CalamineCalamine and Zinc Oxide and Phenol

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