FDA.reportPublic FDA data

HDX Hand Sanitizer

Manufacturer
JVL Laboratories, Inc.
Effective date
2021-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:44:52

Label at a glance#

ProductHDX Hand Sanitizer
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

for occasional and personal use rub thoroughly into hands for at least 30 seconds. allow to dry children under 6 years should be supervised when using this product

Storage and handling

store at temperature below 110 F (43 C) may discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from source of heat or fire

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for occasional and personal use
  • rub thoroughly into hands for at least 30 seconds. allow to dry
  • children under 6 years should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

  • store at temperature below 110 F (43 C)
  • may discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe Barbadensis Leaf Juice, Isopropyl Myistate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Ethylene Brassylate

OTC - QUESTIONS SECTION

Questions or Comments? 1-866-695-3030

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HDX Hand Sanitizer (gel) NDC: 78253-0004-1

473 mL473 mL

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78253-000478253-0004-1

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
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ETHYLENE BRASSYLATE9A87HC7RODIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e94a3d17-5653-3e64-e053-2995a90aa402c250fc57-4b3e-9233-e053-2995a90a8e5a2022-09-22WarningsExact identifier
spl set id: c250fc57-4b3e-9233-e053-2995a90a8e5a

Reported adverse events (FAERS/openFDA)#

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