Surgical and healthcare personnel hand antiseptic with moisturizers

Manufacturer
EPOXEMEX, S.A. DE C.V. | AY CONSULTING SERVICES, LLC
Effective date
2022-06-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:57:47

Label at a glance#

ProductSurgical and healthcare personnel hand antiseptic with moisturizers
Active ingredientCHLORHEXIDINE GLUCONATE, ALCOHOL
Label structure13 sections

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Chlorhexidine Gluconate 1% v/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Surgical hand Antiseptic, Healthcare personnel hand Antiseptic

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79996-700-04

1000 mL NDC 79996-700-041000 mL NDC 79996-700-04

4000 mL NDC 79996-700-05

4000 mL NDC 79996-700-054000 mL NDC 79996-700-05

20000 mL NDC 79996-700-06

2000 mL NDC 79996-700-062000 mL NDC 79996-700-06

1000 mLNDC: 79996-700-01

1000 mL NDC: 79996-700-011000 mL NDC: 79996-700-01

4000 mL NDC: 79996-700-02

4 L NDC: 79996-700-02 SURGICAL AND HEALTHARE PERSONNEL HAND ANTISEPTIC4 L NDC: 79996-700-02 SURGICAL AND HEALTHARE PERSONNEL HAND ANTISEPTIC

20000 mL NDC: 79996-700-03

20000 mL NDC: 79996-700-0320000 mL NDC: 79996-700-03

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79996-70079996-700-01, 79996-700-02, 79996-700-03, 79996-700-04, 79996-700-05, 79996-700-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43d1dc18-7d0f-824f-e063-6394a90a7021b63792a1-27f8-eeab-e053-2a95a90adf4d2023-12-04WarningsExact identifier
spl set id: b63792a1-27f8-eeab-e053-2a95a90adf4d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.