FDA.reportPublic FDA data

Hyalolex Hand Sanitizer with Lavender and Zinc

Manufacturer
India Globalization Capital Inc
Effective date
2023-02-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:32:21

Label at a glance#

ProductHyalolex Hand Sanitizer with Lavender and Zinc
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 20C-25C (68F-77F) May discolor certain fabrics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Hand Sanitizer, Antimicrobial

Use

INDICATIONS & USAGE SECTION

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 the eyes In case of contact, rinse eyes thoroughly 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 occurs

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, deionized water, Aloe Vera, Carbomer, Xanthan Gum, Zinc Oxide, Lavender Oil

RECENT MAJOR CHANGES SECTION

Updated per the product label

Hyalolex Hand Sanitizer wth Lavender and Zinc Sulfate and Paraben Free 70% Ethyl Alcohol Antimicrobial. Kills Germs Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL Label3785 mL Label472 mL Label472 mL Label236 mL Label236 mL Label

236 mL 75540-528-08

472 mL 75540-528-16

3785 mL 75540-528-28

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75540-528-082023-05-01C16284748780-1f386c649-a6ab-0266-e053-dadaa90a7c1aHyaloex Hand Sanitizer with Lavender and Zinc
75540-528-162023-05-01C16284748780-1f386c649-a6ab-0266-e053-dadaa90a7c1aHyaloex Hand Sanitizer with Lavender and Zinc
75540-528-282023-05-01C16284748780-1f386c649-a6ab-0266-e053-dadaa90a7c1aHyaloex Hand Sanitizer with Lavender and Zinc
75540-528-082023-01-30C16284748780-1f386c649-a6ab-0266-e053-dadaa90a7c1aHyaloex Hand Sanitizer with Lavender and Zinc
75540-528-162023-01-30C16284748780-1f386c649-a6ab-0266-e053-dadaa90a7c1aHyaloex Hand Sanitizer with Lavender and Zinc
75540-528-282023-01-30C16284748780-1f386c649-a6ab-0266-e053-dadaa90a7c1aHyaloex Hand Sanitizer with Lavender and Zinc

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75540-52875540-528-08, 75540-528-16, 75540-528-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC ALUMUGR874142RIACT
XANTHAN GUMTTV12P4NEEIACT
ALOE VERA LEAFZY81Z83H0XIACT
LAVENDER OILZBP1YXW0H8IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9804Q93RCW27EIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
f5162013-3d8a-a7b7-e053-2995a90aa3d1a470e816-d760-43af-e053-2995a90ab9062023-02-19WarningsExact identifier
spl id: f5162013-3d8a-a7b7-e053-2995a90aa3d1
spl set id: a470e816-d760-43af-e053-2995a90ab906

Reported adverse events (FAERS/openFDA)#

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