Pantero Gel Hand Sanitizer 70% Alcohol

Pantero Gel Hand Sanitizer 70% Alcohol (bulk) by

Drug Labeling and Warnings

Pantero Gel Hand Sanitizer 70% Alcohol (bulk) by is a Otc medication manufactured, distributed, or labeled by Pantero, Frestedt Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PANTERO GEL HAND SANITIZER 70% ALCOHOL (BULK)- alcohol 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.

----------

Pantero Gel Hand Sanitizer 70% Alcohol

Active Ingredient(s)

Alcohol 70% 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, 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 15-30 degrees C (59-86 degrees F)
• Avoid freezing and excessive heat above 40 degrees C (104 degrees F)

Inactive ingredients

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

Package Label - Principal Display Panel

1040988 mL NDC: 74153-380-27

PANTERO GEL HAND SANITIZER 70% ALCOHOL (BULK) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74153-380
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74153-380-27	1040988 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/17/2020	09/10/2021

Labeler - Pantero (116669041)

Registrant - Frestedt Inc. (018853696)

Establishment
Name	Address	ID/FEI	Business Operations
Pantero		116669041	manufacture(74153-380) , pack(74153-380) , label(74153-380) , repack(74153-380) , relabel(74153-380)

Revised: 9/2021

Document Id: cbab3520-ff15-05d9-e053-2a95a90a20ba

34390-5

Set id: af76177c-fa72-39ea-e053-2a95a90a9de7

Version: 2

Effective Time: 20210910