<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84507-039-01
</NDCCode>
<PackageDescription>
500 mL in 1 BOTTLE (84507-039-01)
</PackageDescription>
<NDC11Code>
84507-0039-01
</NDC11Code>
<ProductNDC>
84507-039
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Coolkesi Botin Sham-poo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hair Care
</NonProprietaryName>
<DosageFormName>
SHAMPOO
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250611
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
505G(a)(3)
</ApplicationNumber>
<LabelerName>
Guangdong Miaolian Cosmetics Co., Ltd.
</LabelerName>
<SubstanceName>
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL; ROSA DAMASCENA FLOWER OIL; ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL
</SubstanceName>
<StrengthNumber>
.1; .1; .1
</StrengthNumber>
<StrengthUnit>
mg/100mL; mg/100mL; mg/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250611
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>