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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74153-372(NDC: 75029-200)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74153-372-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020	09/10/2021

Labeler - Pantero (116669041)

Registrant - Frestedt Inc. (018853696)

Establishment
Name	Address	ID/FEI	Business Operations
Pantero		116669041	repack(74153-372) , relabel(74153-372)

Revised: 9/2021

Document Id: cbab2b59-6930-4409-e053-2a95a90abb1b

34390-5

Set id: adf0ca82-c131-833c-e053-2a95a90abd32

Version: 2

Effective Time: 20210910