Ben E. Keith FIHS

Manufacturer: Ben E. Keith Foods
Effective date: 2025-03-03
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:56:34

Label at a glance#

ProductBen E. Keith FIHS

Active ingredientBENZALKONIUM CHLORIDE

Label structure7 sections

Indications and uses

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Dosage and administration

To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antibacterial Agent

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Avoid contact with eyes

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, flush with water.

OTC - ASK DOCTOR SECTION

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Directions

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA.

Representative label and principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL-FREE

BEN E. KEITH

ESSENTIALS

FOAMINIG

INSTANT HAND

SANITIZER

REORDER

#885610

Net Contents: 1000 mL (33.8 Fl. Oz.)

DISTRIBUTED BY Ben E. Keith Foods

FT. WORTH, TX 76101

representative label

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
50980-207-31	2022-06-03	C162847	48780-1	d6a99b39-48db-a426-e053-dadaa90af4c2	Drug Facts
50980-207-31	2022-01-28	C162847	48780-1	d6a99b39-48db-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50980-207-12	Ben E. Keith FIHS	1000 mL in 1 BAG	SOLUTION	1000		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50980-207	BEN E. KEITH FIHS (BENZALKONIUM CHLORIDE) SOLUTION [BEN E. KEITH FOODS]	5	Current NDC, Legacy NDC, 1 package rows	20250305_4ca21370-1ecf-42c6-9c32-79cf994c336b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Ben E. Keith FIHS
Benzalkonium Chloride
BENZALKONIUM
WATER
EDETATE SODIUM
COCAMIDOPROPYL BETAINE
PEG-7 GLYCERYL COCOATE
PROPYLENE GLYCOL
PHENOXYETHANOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE, DL-

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50980-207	50980-207-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
WATER	059QF0KO0R	IACT
EDETATE SODIUM	MP1J8420LU	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
PEG-7 GLYCERYL COCOATE	VNX7251543	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT

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
Ben E. Keith FIHS	BENZALKONIUM CHLORIDE	Ben E. Keith Foods	4ca21370-1ecf-42c6-9c32-79cf994c336b	2025-03-03	Warnings	Exact identifier ndc (package): 50980-207-12 ndc (product): 50980-207 ndc11 (package): 50980020712 spl id: 09c78743-cb8d-483c-a5f5-781cc220c0e2 spl set id: 4ca21370-1ecf-42c6-9c32-79cf994c336b

Reported adverse events (FAERS/openFDA)#

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