Essential Hand Sanitizer Gel by Genesis Custom Chemical Blending / Swiss American / Genesis Custom Chemical Blending Hand Sanitizer Gel

Essential Hand Sanitizer Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

ESSENTIAL HAND SANITIZER GEL- alcohol gel 
Genesis Custom 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 acrylate copolymer*, ethyl methacrylate*, fragrance (parfum), glycerin, purified water USP, triethanolamine

Package Label - Principal Display Panel

75 mL NDC: 75125-2100-0 Genesis Gelled 2.54oz 75 mL

Package Label - Principal Display Panel

473.18 mL NDC: 75125-2100-0 Genesis Gelled 16oz - 473.18 mL

Package Label - Principal Display Panel

3785.41 mL NDC: 75125-2100-5 Genesis Gelled 1gal - 3785.41 mL

Package Label - Principal Display Panel

Genesis Gelled 5gal - 18927.1 mL18927.1 mL NDC: 75125-2100-6

Package Label - Principal Display Panel

1249185.89 mL NDC: 75125-2100-9 Genesis Gelled 330gal - 1249185.89 mL

ESSENTIAL HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75125-2100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL74.25 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 4.48 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.88 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 19.14 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75125-2100-175 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/202012/31/2021
2NDC: 75125-2100-0473.18 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202012/31/2021
3NDC: 75125-2100-53785.41 mL in 1 JUG; Type 0: Not a Combination Product06/01/202012/31/2021
4NDC: 75125-2100-618927.1 mL in 1 PAIL; Type 0: Not a Combination Product06/01/202012/31/2021
5NDC: 75125-2100-91249185.89 mL in 1 TANK; Type 0: Not a Combination Product06/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/202012/31/2021
Labeler - Genesis Custom Chemical Blending (080744214)
Registrant - Genesis Custom Chemical Blending (080744214)
Establishment
NameAddressID/FEIBusiness Operations
Swiss American080170933repack(75125-2100)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Custom Chemical Blending 080744214manufacture(75125-2100)

Revised: 12/2021