FDA Label for Sci 80 Hand Sanitizer

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:

• 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.

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 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand sanitizer

Use

for hand-washing to decrease bacteria on the skin -recommended for repeated use.

Warnings

for external use only - Flammable. Keep away from heat and flame.

Do Not Use

• in children less than 2 months of age
• on open skin wounds

Otc - When Using

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 serious condition. Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center immediately.

Otc - Stop Use

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

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 Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

946 mL NDC: 55549-001-32

or

1892 mL NDC: 55549-001-64

or

3785 mL NDC: 55549-001-01

or

118927 mL NDC: 55549-001-05

or

946353 mL NDC: 55549-001-25

or

1135500 mL NDC: 55549-001-30