Pantero Hand Sanitizer 75% Isopropyl Alcohol (bulk)

Pantero Hand Sanitizer 75% Isopropyl Alcohol (bulk) by

Drug Labeling and Warnings

Pantero Hand Sanitizer 75% Isopropyl Alcohol (bulk) by is a Otc medication manufactured, distributed, or labeled by Pantero, Frestedt, Inc., Pantero, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PANTERO HAND SANITIZER 75% ISOPROPYL ALCOHOL (BULK)- isopropyl alcohol 75% liquid 
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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Pantero Hand Sanitizer 75% Isopropyl Alcohol (bulk)

Active Ingredient(s)

Isopropyl Alcohol 75% v/v.

Purpose

Antiseptic

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

• On children less than 2 months of age
• On open skin wounds

When using this product keep out of eyes, ears, 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 15-30 degrees C (59-86 degrees F)
• Avoid freezing and excessive heat above 40 degrees C (104 degrees F)

Inactive ingredients

Glycerin, Hydrogen Peroxide, Purified Water USP

Pantero Hand Sanitizer 75% Isopropyl Alcohol (bulk)

1040988 ml NDC: 74153-220-27

PANTERO HAND SANITIZER 75% ISOPROPYL ALCOHOL (BULK) 
isopropyl alcohol 75% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74153-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74153-220-27	1040988 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/25/2020	09/10/2021

Labeler - Pantero (116669041)

Registrant - Frestedt, Inc. (018853696)

Establishment
Name	Address	ID/FEI	Business Operations
Pantero, Inc.		116669041	manufacture(74153-220) , pack(74153-220) , label(74153-220) , relabel(74153-220) , repack(74153-220)

Revised: 9/2021

Document Id: cbab15cf-a20a-8ee8-e053-2995a90a2971

34390-5

Set id: b0126c96-ee07-bba4-e053-2995a90a750e

Version: 2

Effective Time: 20210910