RINSE FREE HAND CLEANSER- alcohol gel 
Lune & Evergreen Soap Company LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rinse Free Hand Wash

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)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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.

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.

Directions

Other information

Inactive ingredients

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

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

59 mL 73909-0918-2

59 mL label

Drug Facts label

drug facts

RINSE FREE HAND CLEANSER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73909-0918
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) 1.25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73909-0918-1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
2NDC:73909-0918-259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Lune & Evergreen Soap Company LLC (048856675)

Revised: 4/2020
Document Id: a44fa791-6c45-b488-e053-2a95a90a4e46
Set id: a44f9fac-bede-b27e-e053-2a95a90a0de8
Version: 1
Effective Time: 20200427
 
Lune & Evergreen Soap Company LLC