FDA Label for Hypex Antibacterial Hand Sanitizer
View Indications, Usage & Precautions
Hypex Antibacterial Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Jordan Chemical Industries Co. Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- Ethanol 70%
- Triethanolamine 0.34ml
- water
- Hydrogen Peroxide 0.125
- alpha-tocopherol 0.0003
- carbomer 940 0.36
- 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
Otc - 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
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs.
Otc - 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
500 ml NDC: 78060-001-01 Label
500 ml NDC 78060-001-01 bottle:
110ml NDC 78060-001-02 label
110ml NDC 78060-001-02 bottle
* Please review the disclaimer below.