NDC 63002-003

PROTECT 8

Benzalkonium Chloride

PROTECT 8 is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Advanced Hygienics Llc. The primary component is Benzalkonium Chloride.

Product ID63002-003_001415e4-c6c6-4505-b5dd-f9baa6182e26
NDC63002-003
Product TypeHuman Otc Drug
Proprietary NamePROTECT 8
Generic NameBenzalkonium Chloride
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2017-05-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameAdvanced Hygienics LLC
Substance NameBENZALKONIUM CHLORIDE
Active Ingredient Strength1 g/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63002-003-33

9.76 mL in 1 BOTTLE, SPRAY (63002-003-33)
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63002-003-33 [63002000333]

PROTECT 8 LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-15

NDC 63002-003-95 [63002000395]

PROTECT 8 LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-16

NDC 63002-003-99 [63002000399]

PROTECT 8 LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-15

NDC 63002-003-75 [63002000375]

PROTECT 8 LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-14
Marketing End Date2019-08-01

NDC 63002-003-50 [63002000350]

PROTECT 8 LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
BENZALKONIUM CHLORIDE1.3 g/mL

OpenFDA Data

SPL SET ID:924afbb0-0d3a-4d62-abbd-7cc1f88ddd92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1020365

    • NDC Crossover Matching brand name "PROTECT 8" or generic name "Benzalkonium Chloride"

    NDCBrand NameGeneric Name
    63002-003PROTECT 8PROTECT 8
    0363-7110Antisepticbenzalkonium chloride
    0498-0402AntisepticBenzalkonium chloride
    0498-0501Antiseptic ToweletteBenzalkonium chloride
    0404-6735BZKbenzalkonium chloride
    0404-5824BZK ToweletteBENZALKONIUM CHLORIDE
    0404-4445Hand Sanitizerbenzalkonium chloride
    0363-0082Hand washBenzalkonium chloride
    0363-0651Hand WashBenzalkonium chloride
    0363-0683Hand WashBenzalkonium chloride
    0363-0644Hand wipesBenzalkonium chloride
    0395-8010HUMCO MerthiolateBenzalkonium Chloride
    0395-9122MerthiolateBenzalkonium Chloride
    0363-0554NiceBenzalkonium chloride
    0498-8043North Safety First Aid Kit 019740-0027L/Z019740-0027LBenzalkonium Chloride
    0498-8046North Safety First Aid Kit 019740-4526Benzalkonium Chloride
    0498-8048North Safety First Aid Kit 019745-0032LBenzalkonium Chloride
    0498-8042North Safety First Aid Kit 019746-0032LBenzalkonium Chloride
    0498-8047North Safety First Aid Kit SF00002054Benzalkonium Chloride
    0498-8054North Safety First Aid Kit SF00004415Benzalkonium Chloride
    0498-8053North Safety First Aid Kit Z019846Benzalkonium Chloride
    0498-8051North Safety First Aid Kit Z130023LBenzalkonium Chloride
    0295-9049Stay Safe Hand Sanitizer Alcohol Freebenzalkonium chloride
    0363-7215STUDIO 35BENZALKONIUM CHLORIDE
    0363-7210STUDIO 35 BEAUTYBENZALKONIUM CHLORIDE
    0363-0242WalgreenBENZALKONIUM CHLORIDE
    0363-7211WalgreensBENZALKONIUM CHLORIDE
    0363-9002Walgreens Citrus Antibacterial Foaming HandBenzalkonium Chloride
    0363-9000Walgreens Fresh Antibacterial Foaming HandBenzalkonium Chloride
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