Insti-San Gel Hand Sanitizer 70% Ethanol

Insti-San Gel Hand Sanitizer by

Drug Labeling and Warnings

Insti-San Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pantero, Frestedt Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTI-SAN GEL HAND SANITIZER- 70% ethanol gel hand sanitizer gel 
Pantero

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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Insti-San Gel Hand Sanitizer 70% Ethanol

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that can potentially 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.

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)
  • May discolor some fabrics
  • May damage wood finishes or plastics

Inactive ingredients

Fragrance, Glycerin, Isopropyl Alcohol, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Purified Water USP

Package Label - Principal Display Panel

3785 mL NDC: 74153-372-01 3785 mL label

INSTI-SAN GEL HAND SANITIZER 
70% ethanol gel hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74153-372(NDC: 75029-200)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74153-372-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/31/202009/10/2021
Labeler - Pantero (116669041)
Registrant - Frestedt Inc. (018853696)
Establishment
NameAddressID/FEIBusiness Operations
Pantero116669041repack(74153-372) , relabel(74153-372)

Revised: 9/2021

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