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Antiseptic Hand Rub



SPL UNCLASSIFIED SECTION

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

The hand rub 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:

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

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic


Purpose

Antiseptic, Hand Rub


Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.


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

OTC - WHEN USING SECTION

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.


OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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, hydrogen peroxide, purified water USP


Alcohol Antiseptic 80%Topical SolutionAntiseptic Hand RubNon-sterile Solution

5 ml 0.17fl.OZ NDC: 73107-102-40


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ml 1fl.OZ NDC: 73107-102-30


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 ml 1.7fl.OZ NDC: 73107-102-31


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85 ml 2.8fl.OZ NDC: 73107-102-32


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 ml 3.4fl.OZ NDC: 73107-102-33


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 ml 5fl.OZ NDC: 73107-102-34


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

200 ml 6.7fl.OZ NDC: 73107-102-35


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

250 ml 8.5fl.OZ NDC: 73107-102-36


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml 16.9fl.OZ NDC: 73107-102-37


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 ml 33.8fl.OZ NDC: 73107-102-36


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5000 ml 169fl.OZ NDC: 73107-102-39