Hand Sanitizer - Orange Blossom

Manufacturer: Phenom Marketing Group, Inc.
Effective date: 2022-02-01
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:47:53

Label at a glance#

ProductHand Sanitizer - Orange Blossom

Active ingredientBENZALKONIUM CHLORIDE, ALCOHOL

Label structure12 sections

Dosage and administration

Spray product on hands to cover all surfaces Rub hands together until dry Supervise children under 6 years

Storage and handling

Store below 110F

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 85% v/v. Purpose: Antiseptic

Benzalkonium Chloride 0.1%. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antiseptic, Antimicrobial

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

On children under 2 months
On broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs and persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help

Directions

DOSAGE & ADMINISTRATION SECTION

Spray product on hands to cover all surfaces
Rub hands together until dry
Supervise children under 6 years

Other information

STORAGE AND HANDLING SECTION

Store below 110F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Fragrance, purified water, vegetable glycerin

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL NDC: 80038-004-01

2oz Orange Blossom label

236 mL NDC: 80038-004-02

8oz Orange Blossom label

946 mL NDC: 80038-004-03

32oz Orange Blossom label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2398848	benzalkonium chloride 0.1 % / ethanol 85 % Topical Spray	PSN	2
2398848	benzalkonium chloride 1 MG/ML / ethanol 0.85 ML/ML Topical Spray	SCD	2
2398848	benzalkonium chloride 0.1 % / ethanol 85 % Topical Spray	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80038-004-01	2023-07-28	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-02	2023-07-28	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-03	2023-07-28	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-01	2022-02-01	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-02	2022-02-01	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-03	2022-02-01	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-01	2022-01-28	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-02	2022-01-28	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5
80038-004-03	2022-01-28	C162847	48780-1	d6a99b39-e381-a426-e053-dadaa90af4c2	b1082da7-c440-1a5a-e053-2995a90a59d5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80038-004-01	Hand Sanitizer - Orange Blossom	59 mL in 1 BOTTLE, SPRAY	LIQUID	59	2
80038-004-02	Hand Sanitizer - Orange Blossom	236 mL in 1 BOTTLE, SPRAY	LIQUID	236	2
80038-004-03	Hand Sanitizer - Orange Blossom	946 mL in 1 BOTTLE, PLASTIC	LIQUID	946	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80038-004	HAND SANITIZER - ORANGE BLOSSOM (ALCOHOL) LIQUID [PHENOM MARKETING GROUP, INC.]	2	Legacy NDC, 3 package rows	20220202_b1082da7-c440-1a5a-e053-2995a90a59d5.zip

Products#

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

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

Hand Sanitizer - Orange Blossom
ALCOHOL
GLYCERIN
WATER
BENZALKONIUM CHLORIDE
BENZALKONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80038-004	80038-004-01, 80038-004-02, 80038-004-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB
ALCOHOL	3K9958V90M	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
d6fb364f-efa1-3591-e053-2a95a90a69cd			b1082da7-c440-1a5a-e053-2995a90a59d5	2022-02-01	Warnings	Exact identifier spl id: d6fb364f-efa1-3591-e053-2a95a90a69cd spl set id: b1082da7-c440-1a5a-e053-2995a90a59d5

Reported adverse events (FAERS/openFDA)#

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