SURGICAL AND HEALTHCARE PERSONNEL HAND ANTISEPTIC WITH MOISTURIZERS- alcohol liquid

Surgical and healthcare personnel hand antiseptic with moisturizers by

Drug Labeling and Warnings

Surgical and healthcare personnel hand antiseptic with moisturizers by is a Otc medication manufactured, distributed, or labeled by EPOXEMEX, S.A. DE C.V., AY CONSULTING SERVICES, LLC. 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. 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.
2. Chlorhexidine Gluconate (1%, volume/weight (v/w) )
3. Aloe Barbadensis Leaf Extract
4. Fragance
5. Glycerin
6. Polyethylene Glycol
7. 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 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

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, sensitization or allergic reaction 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

• 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

Package Label - Principal Display Panel

1000 mL NDC: 79996-700-04

4000 mL NDC: 79996-700-05

20000 mL NDC: 79996-700-06

1000 mLNDC: 79996-700-01

4000 mL NDC: 79996-700-02

20000 mL NDC: 79996-700-03

INGREDIENTS AND APPEARANCE

SURGICAL AND HEALTHCARE PERSONNEL HAND ANTISEPTIC WITH MOISTURIZERS 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79996-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79996-700-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
2	NDC: 79996-700-02	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
3	NDC: 79996-700-03	20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
4	NDC: 79996-700-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021
5	NDC: 79996-700-05	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021
6	NDC: 79996-700-06	20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - EPOXEMEX, S.A. DE C.V. (814573127)

Registrant - AY CONSULTING SERVICES, LLC (078311971)

Establishment
Name	Address	ID/FEI	Business Operations
EPOXEMEX, S.A. DE C.V.		814573127	manufacture(79996-700)