Hyalolex Hand Sanitizer with Lavender and Zinc

Manufacturer
India Globalization Capital
Effective date
2023-01-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:40:02

Label at a glance#

ProductHyalolex Hand Sanitizer with Lavender and Zinc
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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

Storage and handling

Store at 20-25C (68-77F) May discolor certain abric

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Store at 20-25C (68-77F)
  • May discolor certain abric

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

RECENT MAJOR CHANGES SECTION

Editorial revisions to the wording

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Package Label - Principal Display Panel Hylolex Hand Sanitizer Lavender + Zinc Sulfate + Paraben Free 70% Ethyl Alcohol Kills Germs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 mL Label59 mL Label59 mL NDC: 75540-528-02

HX-HandSanitizer-041020-Lavender2 (1).jpg

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
75540-52875540-528-02

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
f1a01bba-46bc-af4e-e053-2a95a90a0f67a361357b-73bf-e674-e053-2995a90ab4642023-01-06WarningsExact identifier
spl id: f1a01bba-46bc-af4e-e053-2a95a90a0f67
spl set id: a361357b-73bf-e674-e053-2995a90ab464

Reported adverse events (FAERS/openFDA)#

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