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LARA MED ANTIBACTERIAL HAND&SKIN CLEANER


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) (60.7%, volume/volume(v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Isopropyl Alcohol 8.7% (v/v)
  • Glycerol (1.3% (v/v)
  • BUTANE (3.25% (v/v)
  • PROPANE (0.875% (v/v)
  • ISOBUTANE (0.875% (v/v)
  • FD&C Blue No.1 (0.0001% (v/v)
  • Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 60.7% v/v. Purpose: Antiseptic

Isopropyl Alcohol 8.7% v/v. Purpose: Antiseptic


Purpose

Antiseptic, Hand Sanitizer


Use

In order to maintain personel hygiene, it can be easily used in any environment that does not require soap without dilution.

For use when soap and water are not available. Ready to use. For use in examinations and clinics where surgical skin hygiene needed. For use before injection, and surgery and intensive care wherever hand and skin hygiene is required.


Warnings

For external use only. If irritation occurs, discontinue use.


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 the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation, sensitization or allergin reaction 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.

Flammable Do not use while smoking or near heat or flame


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

  • use 3 ml product in your palm and hands. Rubbed well for 30 seconds. 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 between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Keep away sunlight.
  • Pressurized container: Do not pierce or burn, even after use.

Inactive ingredients

Butane, Glycerol, Propane, Isobutane, FD&C Blue No.1, Water