Essential Hand Sanitizer by Genesis Chemical Blending Hand Sanitizer Gel

Essential Hand Sanitizer by

Drug Labeling and Warnings

Essential Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Genesis Chemical Blending. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ESSENTIAL HAND SANITIZER- alcohol gel 
Genesis Chemical Blending

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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Hand Sanitizer Gel

Active Ingredient(s)

Alcohol 72% 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

ethyl methacrylate*, fragrance (parfum), glycerin, purified water USP, triethanolamine

Package Label - Principal Display Panel

59.15 mL NDC: 75125-2201-1 Genesis Gelled 2oz - 59.15 mL

Package Label - Principal Display Panel

118.29 mL NDC: 75125-2201-2 Genesis Gelled 4oz - 118.29 mL

Package Label - Principal Display Panel

354.88 mL NDC: 75125-2201-3

Genesis Gelled 12oz - 354.88 mL

ESSENTIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75125-2201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL74.33 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 18.722 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.88 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL  in 100 mL
ETHYL METHACRYLATE (UNII: 80F70CLT4O) 4.82 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75125-2201-159.15 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/202012/31/2021
2NDC: 75125-2201-2118.29 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/202012/31/2021
3NDC: 75125-2201-3354.88 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/202012/31/2021
Labeler - Genesis Chemical Blending (080744214)
Registrant - Genesis Chemical Blending (080744214)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Chemical Blending080744214manufacture(75125-2201)

Revised: 12/2021
Document Id: d2a6c866-3f0f-20f1-e053-2995a90a26cc
Set id: a88946ed-7e84-3c2e-e053-2a95a90af33d
Version: 2
Effective Time: 20211208