Justrite Gel Hand Sanitizer 70% Alcohol

Justrite Gel Hand Sanitizer by

Drug Labeling and Warnings

Justrite Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by JUSTRITE MANUFACTURING COMPANY, L.L.C., Pantero. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JUSTRITE GEL HAND SANITIZER- 70% ethyl alcohol gel gel 
JUSTRITE MANUFACTURING COMPANY, L.L.C.

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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Justrite Gel Hand Sanitizer 70% Alcohol

Active Ingredient

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 maybe signs of a serious condition.

Keep out of the 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 six years of age when using this product to avoid swallowing.

Other Information

• Store between 15-30 oC (59-86 oF)
• Avoid freezing and excessive heat above 40 oC (104 oF)
• May discolor some fabrics

Inactive ingredients

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

Questions or Comments?

Call 1-800-798-9250, custserv@justrite.com

Package Label - Principal Display Panel

NDC: 81144-376-02:

NDC: 81144-376-08:

NDC: 81144-376-16:

NDC: 81144-376-32:

NDC: 81144-376-01:

JUSTRITE GEL HAND SANITIZER 
70% ethyl alcohol gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81144-376
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
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81144-376-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
2	NDC: 81144-376-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
3	NDC: 81144-376-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
4	NDC: 81144-376-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020
5	NDC: 81144-376-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/19/2020	09/10/2021

Labeler - JUSTRITE MANUFACTURING COMPANY, L.L.C. (005106018)

Registrant - Pantero (116669041)

Establishment
Name	Address	ID/FEI	Business Operations
Pantero		116669041	manufacture(81144-376) , pack(81144-376) , label(81144-376) , repack(81144-376) , relabel(81144-376)

Revised: 9/2021

Document Id: cbaaf4c6-77eb-ba2c-e053-2995a90a5cda

34390-5

Set id: b47dc762-8c29-56d7-e053-2a95a90a1c28

Version: 2

Effective Time: 20210910