FRUSIRNANA HAND SANITIZER: Package Insert and Label Information

FRUSIRNANA HAND SANITIZER- alcohol solution
MH Biotechnology Corporation Ltd

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 follow United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

  • 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 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.

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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, purified water USP

Package Label — Principal Display Panel

120 mL NDC: 80459-001-01

FRUSIRNANA HAND SANITIZER
alcohol solution
Product Information
Product Type Item Code (Source) NDC:80459-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 94.8 mL in 120 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 3.6 mL in 120 mL
WATER 20.64 mL in 120 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80459-001-01 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/02/2020
Labeler — MH Biotechnology Corporation Ltd (656212996)
Registrant — MH Biotechnology Corporation Ltd (656212996)
Establishment
Name Address ID/FEI Operations
MH Biotechnology Corporation Ltd 656212996 manufacture (80459-001), label (80459-001)

Revised: 09/2020 MH Biotechnology Corporation Ltd

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