LARAMED ANTIBACTERIAL ALCOHOL WIPES

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:

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) (65%, weight/weight (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
• Isopropanol 10%, (w/w)
• Benzalkonium Chloride 0.05%, (w/w)
• Glycerol
• Tocopherol
• Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 65% w/w. Purpose: Antiseptic

Isopropanol 10% w/w. Purpose: Antiseptic

Benzalkonium chloride 0.05% w/w. 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 liquid and vapor.

Do not use

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

OTC - WHEN USING SECTION

When using this product do not use in or near eyes. 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

• Open package, removeonewetwipetocleanyourhands| and body. Reseal, keep closed to prevent evaporation. Allow to dry without wiping. Discard properly after use.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 110F ( 43 C)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surface.

Inactive ingredients

Glycerol Tocopherol

purified water USP