Hyalolex Hand Sanitizer

Manufacturer
India Globalization Capital, Inc.
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:22:02

Label at a glance#

ProductHyalolex Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands with product and briskly rub hands together until dry. Supervise children under 6 years in use of this product

Storage and handling

Store between 20-25C (68-77F) May discolor certain fabrics

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

Alcohol 70% v/v. Purpose: Sanitizer, Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce germs on the skin.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

In or near eyes. In case of contact, rinse eyes throughly with water

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use if irritation reappears

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands with product and briskly rub hands together until dry.
  • Supervise children under 6 years in use of this product

Other information

STORAGE AND HANDLING SECTION

  • Store between 20-25C (68-77F)
  • May discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, acrylate copolymer, glycerin, carbomer, propylene glycol, aloe leaf extract, lemon oil, hydroxypropyl methyl cellulose, tocopherul acetate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL Bottle Label59 mL Bottle Label59 mL NDC: 75540-253-02

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75540-25375540-253-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
f45df865-05e2-c7aa-e053-2995a90adccab1afb819-ceef-4f3d-e053-2995a90a11932023-02-10WarningsExact identifier
spl set id: b1afb819-ceef-4f3d-e053-2995a90a1193

Reported adverse events (FAERS/openFDA)#

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