Label at a glance#

ProductPROTECT 8

Active ingredientBENZALKONIUM CHLORIDE

Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Pump a small amount of foam onto hands.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROTECT 8

Hand

Sanitizer

Alcohol Free

Fragrance Free

Gentle on Skin

16.9 FL OZ (500mL)

container label2 container label2

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1020365	Benzalkonium (Topical)	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020365	benzalkonium chloride 0.13 % Topical Foam	PSN	5
1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD	5
1020365	benzalkonium chloride 0.13 % Topical Foam	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63002-003-33	2024-01-30	C162847	48780-1	1030e365-4a48-111a-e063-dadaa90a10e2	Drug Facts
63002-003-50	2024-01-30	C162847	48780-1	1030e365-4a48-111a-e063-dadaa90a10e2	Drug Facts
63002-003-95	2024-01-30	C162847	48780-1	1030e365-4a48-111a-e063-dadaa90a10e2	Drug Facts
63002-003-99	2024-01-30	C162847	48780-1	1030e365-4a48-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63002-003-33	PROTECT 8	9.76 mL in 1 BOTTLE, SPRAY	LIQUID	9.76	5
63002-003-50	PROTECT 8	500 mL in 1 BOTTLE	LIQUID	500	5
63002-003-95	PROTECT 8	950 mL in 1 BAG	LIQUID	950	5
63002-003-99	PROTECT 8	50 mL in 1 BOTTLE	LIQUID	50	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63002-003	PROTECT 8 (BENZALKONIUM CHLORIDE) LIQUID [ADVANCED HYGIENICS LLC]	5	Legacy NDC, 4 package rows	20190802_924afbb0-0d3a-4d62-abbd-7cc1f88ddd92.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

PROTECT 8
BENZALKONIUM CHLORIDE
WATER
POLIHEXANIDE
CAPRYLYL GLUCOSIDE
C12-15 PARETH-7
DIMETHICONE
CETRIMONIUM CHLORIDE
LAURTRIMONIUM CHLORIDE
DIHYDROXYETHYL COCAMINE OXIDE
GLYCERETH-17 COCOATE
CITRIC ACID MONOHYDRATE
BENZALKONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63002-003	63002-003-33, 63002-003-99, 63002-003-50, 63002-003-95

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
POLIHEXANIDE	322U039GMF	IACT
CAPRYLYL GLUCOSIDE	V109WUT6RL	IACT
C12-15 PARETH-7	3XY03A79QH	IACT
DIMETHICONE	92RU3N3Y1O	IACT
CETRIMONIUM CHLORIDE	UC9PE95IBP	IACT
LAURTRIMONIUM CHLORIDE	A81MSI0FIC	IACT
DIHYDROXYETHYL COCAMINE OXIDE	8AR51R3BL5	IACT
GLYCERETH-17 COCOATE	3057VPT0KC	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8eeefa0c-ad15-6f6a-e053-2a95a90a3def			924afbb0-0d3a-4d62-abbd-7cc1f88ddd92	2019-07-30	Warnings	Exact identifier spl id: 8eeefa0c-ad15-6f6a-e053-2a95a90a3def spl set id: 924afbb0-0d3a-4d62-abbd-7cc1f88ddd92

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.