HYPEX ANTIBACTERIAL HAND SANITIZER- alcohol gel

Hypex Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Hypex Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jordan Chemical Industries Co. LTD, Jorden Chemical Industries Co. LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Ethanol 70%
2. Triethanolamine 0.34ml
3. water
4. Hydrogen Peroxide 0.125
5. alpha-tocopherol 0.0003
6. carbomer 940 0.36
7. Glycerin 1.45 ml

Active Ingredient(s)

Ethanol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

* To decrease bacteria on skin that could cause diseases

* recommended for repeated use

Warnings

For external use only: hands

Flammable, keep away from heat or flame

WHEN USING

When using this product keep

* Keep out of eyes. In case of contact with eyes, flush thoroughly with water

* do not inhale or ingest

*avoid contact with broken skin

STOP USE

Stop use and ask a doctor if irritation or rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If irritation occurs or swallowed, seek medical help

Directions

• Apply a suitable amount of this product on your hands, rub hands together until dry without wiping.
• For children under 6 years old, use only with adult supervision
• Store at room tempreture.

Inactive ingredients

glycerin, hydrogen peroxide, water, triethanolamine, Vitamin E (lipobeads) , Carbomer

Package Label - Principal Display Panel

110ml NDC: 78060-001-02

INGREDIENTS AND APPEARANCE

HYPEX ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78060-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 g  in 100 g
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)	0.34 g  in 100 g
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	0.0003 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E)	0.36 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78060-001-01	520 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/20/2020
2	NDC: 78060-001-02	115 g in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/20/2020

Labeler - Jordan Chemical Industries Co. LTD (552743080)

Establishment
Name	Address	ID/FEI	Business Operations
Jorden Chemical Industries Co. LTD		552743080	manufacture(78060-001)