Label at a glance#

ProductHands Sanitizer Alcohol Free

Active ingredientBENZALKONIUM CHLORIDE

Label structure8 sections

Label contents#

Full prescribing information#

BENZALKONIUM CHLORIDA 0.13%

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Directions Apply directly to affected area. Repeat every 4 to 6 hours

DOSAGE & ADMINISTRATION SECTION

Directions

warnings - FOR EXTERNALUSE ONLY. If using on an open wound for 10 days or more and it persists or worsens, consult your doctor. Discontinue use if skin irritation or redness develops

WARNINGS SECTION

Warning section

Uses: As a sanitizer to help reduce bacteria on the skin or wound. Recommended for repeated use.

INDICATIONS & USAGE SECTION

Indications and uses

Inactive Ingredients: Deoionized water, ProtAphex, Aloe Vera

INACTIVE INGREDIENT SECTION

Inactive Ingredients

General Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

General Warning only

Kills 99.9% of all viruses. Gentle enough to be applied on face. Proven to keep working hours after application. Help prevent infections. Proven to be gentle on skin tissue an Non-irritating.

OTC - PURPOSE SECTION

General recomendtion

HANDS AND BODY SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ml label bottle

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1049254	Benzalkonium (Topical)	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049254	benzalkonium chloride 0.13 % Topical Solution	PSN	2
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	2
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78527-002-01	2022-07-29	C162847	48780-1	e4f33bdf-abbd-d8a0-e053-dadaa90a6e4e	a8ecbae8-3c57-d3e7-e053-2995a90a1150
78527-002-02	2022-07-29	C162847	48780-1	e4f33bdf-abbd-d8a0-e053-dadaa90a6e4e	a8ecbae8-3c57-d3e7-e053-2995a90a1150

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78527-002-01	Hands Sanitizer Alcohol Free	473 mL in 1 BOTTLE	SOLUTION	473		2
78527-002-02	Hands Sanitizer Alcohol Free	59 mL in 1 BOTTLE	SOLUTION	59		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78527-002	HANDS SANITIZER ALCOHOL FREE (BENZALCONIUM CHLORIDE) SOLUTION [RAPHA HEALTH NETWORK INTERNATIONAL]	2	Legacy NDC, 2 package rows	20211216_a8ecbae8-3c57-d3e7-e053-2995a90a1150.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Hands Sanitizer Alcohol Free
Benzalconium Chloride
WATER
BENZALKONIUM CHLORIDE
BENZALKONIUM
ALOE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
78527-002	78527-002-01, 78527-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
ALOE	V5VD430YW9	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
d334214b-2907-eb9a-e053-2995a90a2f20			a8ecbae8-3c57-d3e7-e053-2995a90a1150	2021-12-15	Warnings	Exact identifier spl id: d334214b-2907-eb9a-e053-2995a90a2f20 spl set id: a8ecbae8-3c57-d3e7-e053-2995a90a1150

Reported adverse events (FAERS/openFDA)#

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

Hands Sanitizer Alcohol Free