FDA.reportPublic FDA data

Rinse Free Hand Cleanser

Manufacturer
Lune & Evergreen Soap Company LLC
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:22

Label at a glance#

ProductRinse Free Hand Cleanser
Active ingredientALCOHOL
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 Rinse free hand cleanser repackaged/labeled.

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 Center for Disease Control recommendations:

  1. Cleaning hands at key times with soap and water or hand sanitizer that contains at least 60% alcohol is one of the most important steps you can take to avoid getting sick and spreading germs to those around you.

The firm does not add other active ingredients. Any additional ingredients added have been precisly measured and do not drop active ingredient below 62% Ethyl Alcohol, and does not impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 62% 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 ingredients

INACTIVE INGREDIENT SECTION

glycerin, Deionized Water, Propylene Glycol, Hydroxypropylcellulose, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 mL NDC: 73909-0918-1 118 mL label118 mL label

59 mL 73909-0918-2

59 mL label59 mL label

Drug Facts label

drug factsdrug facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73909-0918-12022-01-28C16284748780-1d6a99b39-a45a-a426-e053-dadaa90af4c2Rinse Free Hand Wash
73909-0918-22022-01-28C16284748780-1d6a99b39-a45a-a426-e053-dadaa90af4c2Rinse Free Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73909-0918-1Rinse Free Hand Cleanser118 mL in 1 BOTTLE, PUMPGEL1181
73909-0918-2Rinse Free Hand Cleanser59 mL in 1 BOTTLE, DISPENSINGGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73909-0918RINSE FREE HAND CLEANSER (ALCOHOL) GEL [LUNE & EVERGREEN SOAP COMPANY LLC]1Legacy NDC, 2 package rows20200428_a44f9fac-bede-b27e-e053-2a95a90a0de8.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73909-091873909-0918-1, 73909-0918-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)UKE75GEA7FIACT

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
a44fa791-6c45-b488-e053-2a95a90a4e46a44f9fac-bede-b27e-e053-2a95a90a0de82020-04-27WarningsExact identifier
spl id: a44fa791-6c45-b488-e053-2a95a90a4e46
spl set id: a44f9fac-bede-b27e-e053-2a95a90a0de8

Reported adverse events (FAERS/openFDA)#

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