NDC 69927-001

Balmers Cooling Zone 31

Pyrithione Zinc

Balmers Cooling Zone 31 is a Topical Shampoo in the Human Otc Drug category. It is labeled and distributed by Tae Eul Bi Co., Ltd.. The primary component is Pyrithione Zinc.

Product ID69927-001_48173f3e-8435-4f75-9f9c-649192633cad
NDC69927-001
Product TypeHuman Otc Drug
Proprietary NameBalmers Cooling Zone 31
Generic NamePyrithione Zinc
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date2015-07-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart358H
Labeler NameTae Eul Bi Co., Ltd.
Substance NamePYRITHIONE ZINC
Active Ingredient Strength1 g/100mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69927-001-01

500 mL in 1 BOTTLE (69927-001-01)
Marketing Start Date2015-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69927-001-01 [69927000101]

Balmers Cooling Zone 31 SHAMPOO
Marketing CategoryOTC monograph final
Application Numberpart358H
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PYRITHIONE ZINC1.05 g/100mL

OpenFDA Data

SPL SET ID:d3a185a0-3010-4fe3-a113-ddd7cd46d542
Manufacturer
UNII
UPC Code
  • 8809379540061

    • NDC Crossover Matching brand name "Balmers Cooling Zone 31" or generic name "Pyrithione Zinc"

    NDCBrand NameGeneric Name
    69927-001Balmers Cooling Zone 31Balmers Cooling Zone 31
    0363-07552 in 1 DandruffPyrithione zinc
    11344-3112 in 1 DandruffPyrithione zinc
    11344-6122 in 1 DandruffPyrithione zinc
    10096-0220Advance Techniques Keep ClearPYRITHIONE ZINC
    10096-0221Advance Techniques Keep ClearPYRITHIONE ZINC
    10967-650American CrewPyrithione Zinc
    0363-0253DandruffPyrithione zinc
    0869-0153DandruffPyrithione zinc
    11344-253DandruffPyrithione zinc
    11344-531DandruffPyrithione Zinc
    0096-0735DHS ZINCpyrithione zinc
    0363-0688Dry Scalp CarePyrithione Zinc
    11344-309Fresh Mint DandruffPYRITHIONE ZINC
    10812-152Neutrogena Tgel Daily Control 2 in 1Pyrithione Zinc
    10056-006Satinique Anti DandruffPYRITHIONE ZINC
    0363-4673Walgreens Dandruff Plus Conditioner 2 in 1Pyrithione Zinc
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