HAND SANITIZER- isopropyl alcohol solution

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Drug Labeling and Warnings

Array by is a Otc medication manufactured, distributed, or labeled by Sysmex Reagents America, Incorporated. 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. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

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

<p class="First">This is a hand sanitizer manufactured according to the <a href="https://www.fda.gov/media/136289/download" data-mce-href="https://www.fda.gov/media/136289/download">Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry</a>.</p><p>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:</p><ol class="LittleAlpha"><li>Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.</li><li>Glycerol (1.45% v/v).</li><li>Hydrogen peroxide (0.125% v/v).</li><li>Sterile distilled water or boiled cold water.</li></ol><p>The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.</p>

Active Ingredient(s)

Isopropyl 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

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

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

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

Package Label - Principal Display Panel

250 mL NDC: 75474-001-01

Package Label - Principal Display Panel

1000 mL NDC: 75474-001-02

Package Label - Principal Display Panel

473.176 mL (16oz) NDC: 75474-001-03

Package Label - Principal Display Panel

946.35 mL (32oz) NDC: 75474-001-04

INGREDIENTS AND APPEARANCE

  HAND SANITIZER
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75474-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
Hydrogen Peroxide (UNII: BBX060AN9V)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75474-001-01	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2020
2	NDC: 75474-001-02	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/20/2020
3	NDC: 75474-001-03	473.176 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/20/2020
4	NDC: 75474-001-04	946.35 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/20/2020

Labeler - Sysmex Reagents America, Incorporated (834695454)

Registrant - Sysmex Reagents America, Incorporated (834695454)

Establishment
Name	Address	ID/FEI	Business Operations
Sysmex Reagents America, Incorporated		834695454	manufacture(75474-001)