HAND SANITIZER- ethyl alcohol gel 
Olympic Mountain Products, Inc.

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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Essenza 8.5 oz Hand Sanitizer (62%)

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:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (62%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Water (35.31 % v/v)
Glycerin (2.0 % v/v)
Carbomer (0.35 % v/v)
PEG-40 Hydrogenated Castor Oil (0.2 % v/v)
Chloroxylenol (0.1 % v/v)
Sodium Hydroxide (0.04 % v/v)

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)

Alcohol 70% 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

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

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

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

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

Inactive ingredients

Water, Glycerin, Carbomer, Peg-40
Hydrogenated Castor Oil,
Chloroxylenol, Sodium Hydroxide.

Package Label

251 mL NDC: 75951-8099-8

Front

Back

Label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75951-8099
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.35 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 35.31 mL  in 100 mL
CHLOROXYLENOL (UNII: 0F32U78V2Q) 0.1 mL  in 100 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.04 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75951-8099-8251 mL in 1 BOTTLE, PLASTIC; 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 - Olympic Mountain Products, Inc. (103355350)

Revised: 6/2020
Document Id: a85ff3a0-6aa9-605a-e053-2a95a90af727
Set id: a1b0ef4c-9d1e-803d-e053-2a95a90a7a02
Version: 3
Effective Time: 20200618
 
Olympic Mountain Products, Inc.