Hand Sanitizer

Manufacturer
Lustrous Metal Coatings Inc
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:40

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

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. Isopropyl Alcohol (75%, 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

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer 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 heat 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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP, polyacrylate crosspolymer-6

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ml back label59 ml back label59 ml NDC 75582-220-07 59 mL Front label59 mL Front label59 ml NDC 75582-220-07 2011 ml label2011 ml label2011 ml NDC 75582-220-05 237 ml back label237 ml back label237 ml NDC 75582-220-02 3784 ml back label3784 ml back label3784 ml NDC 75582-220-06 3784 ml front label3784 ml front label3784 ml NDC 75582-220-06 946 ml front label946 ml front label946 ml NDC 75582-220-04 473 ml front label473 ml front label473 ml NDC 75582-220-03 237 ml front label237 ml front label237 ml NDC 75582-220-02 118 ml front label118 ml front label118 ml NDC 75582-220-01 118 ml label back118 ml label back118 ml NDC 75582-220-01 473 ml back label473 ml back label473 ml NDC 75582-220-03 946 ml back label946 ml back label946 ml NDC 75582-220-04

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN4
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD4
2285607isopropyl alcohol 75 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75582-220-01Hand Sanitizer118 mL in 1 BOTTLE, PUMPGEL1184
75582-220-02Hand Sanitizer237 mL in 1 BOTTLE, PUMPGEL2374
75582-220-03Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4734
75582-220-04Hand Sanitizer946 mL in 1 BOTTLE, PUMPGEL9464
75582-220-05Hand Sanitizer2011 mL in 1 BOTTLE, PUMPGEL20114
75582-220-06Hand Sanitizer3784 mL in 1 BOTTLE, PLASTICGEL37844
75582-220-07Hand Sanitizer59 mL in 1 BOTTLE, PUMPGEL594
75582-220-08Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL304
75582-220-09Hand Sanitizer177 mL in 1 BOTTLE, PUMPGEL1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75582-220HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [LUSTROUS METAL COATINGS INC]4Legacy NDC, 9 package rows20220128_a46fe9cb-e233-050c-e053-2a95a90ac65d.zip

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
d69565db-1dbc-21b9-e053-2995a90adf0ca46fe9cb-e233-050c-e053-2a95a90ac65d2022-01-27WarningsExact identifier
spl id: d69565db-1dbc-21b9-e053-2995a90adf0c
spl set id: a46fe9cb-e233-050c-e053-2a95a90ac65d

Reported adverse events (FAERS/openFDA)#

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