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Surgical and Healthcare Sanitizer


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) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Chlorhexidine Gluconate (1%, volume/weight (v/w) )
  • Aloe Barbadensis Leaf Extract
  • Fragance
  • Glycerin
  • Polyethylene Glycol
  • Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Chlorhexidine Gluconate 1% v/w. Purpose: Antiseptic


Purpose

Surgical hand Antiseptic, Healthcare personnel hand Antiseptic


Use

Surgical Hand Antiseptic: significally reduces the number of micro organisms on the hands and forearms prior to surgery or patient care.

Healthcare personnel Hand Antiseptic: handwash to help reduce bacteria that can potentially cause disease.


Warnings

For external use only. Flammable. Keep away from heat or flame


Do not use

  • If you are allergic to chlorhexidine gluconate or any other ingredient in this preparation.
  • When using this product:
  • Do not touch eyes with hands that have been treated with this preparation.
  • Keep out of eyes, ears and mouth.
  • May caus srious and permanent eye injure if prmitted to enter and remain in eyes
  • If contact occurs, rinse with cold water right away
  • Do not use routenely if you have wounds which involve more than the superficial layers of the skin

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, sensitization or allergic reaction 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 with care in premature infants or infants undr 2 months of age. These products may cause irritation or chemical burns.
  • Surgical hand antiseptic apply to clean, dry hands and nails. For the first use of each day, clean under nails with a nail stick, dispense one pump (2 ml) into the palm of one hand, dip the fingertips of the opposite hand into the lotion and work it under the nails, spread the remaining lotion over the hand and up to just above the elbow, using another 2 ml of lotion, repeat with the other hand, dispnese another 2 ml of lotion into the other hand, reapply thoroughly to both hands up to the wrists. Allow to dry before donning gloves.
  • Healthcare personnel hand antiseptic apply to clean, dry hands and nails, dispense one pump (2 ml) into the palm of one hand, paying particular attention to the spaces between the fingers and under fingernails, apply the product evenly to cover both hands up to the wrists, allow to dry without wiping.

Other information

  • Store between 20-25C (68-77F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aloe Barbadensis Leaf Extract, Fragance, Glycerin, Polyethylene Glycol, purified water USP