Sanitizer IPA Gel NDC 1100

IPA Essential Hand Sanitizer Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

IPA ESSENTIAL HAND SANITIZER GEL- isopropyl 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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Sanitizer IPA Gel NDC 1100

Active Ingredient(s)

Isopropyl 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

aminomethylpropanol, carbomer interpolymer type a (allyl sucrose crosslinked), fragrance (parfum), glycerin, purified water USP

Package Label - Principal Display Panel

Genesis IPA Gelled 1gal - 3785.41 mL3785.41 mL NDC: 75125-1100-5

Package Label. Principle Display Panel

Genesis IPA Gelled 330gal - 1249185.89 mL1249185.89 mL NDC: 75125-1100-9

IPA ESSENTIAL HAND SANITIZER GEL 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75125-1100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL73.71 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.42 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 24.57 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.19 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.11 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75125-1100-53785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/202012/31/2021
2NDC: 75125-1100-91249185.89 mL in 1 TANK; Type 0: Not a Combination Product11/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/01/202012/31/2021
Labeler - Genesis Custom Chemical Blending (080744214)
Registrant - Genesis Custom Chemical Blending (080744214)
Establishment
NameAddressID/FEIBusiness Operations
Genesis Custom Chemical Blending080744214manufacture(75125-1100)

Revised: 12/2021
Document Id: d2a5dd63-98b8-70d1-e053-2a95a90a8770
Set id: b35e72f6-5892-68e0-e053-2995a90a0352
Version: 2
Effective Time: 20211208