FDA.reportPublic FDA data

AQUAGEL ADVANCED FORMULA

Manufacturer
EPOXEMEX, S.A DE C.V. | AY CONSULTING SERVICES, LLC | EPOXEMEX, S.A. DE C.V.
Effective date
2023-05-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:31:51

Label at a glance#

ProductAQUAGEL ADVANCED FORMULA
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-35C (59-95F) 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. Aloe Barbadensis Leaf Extract
  3. Carbomer
  4. Fragance
  5. Glycerin
  6. Triethanolamine
  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

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

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 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

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-35C (59-95F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Carbomer, Fragance, Glycerin, Triethanolamine, Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 79996-300-22

NDC 79996-300-22 100 mLNDC 79996-300-22 100 mL

60 mL NDC: 79996-300-15

60 ml NDC: 79868-300-1560 ml NDC: 79868-300-15

120 ml NDC: 79996-300-16

120 mL NDC: 79996-300-16120 mL NDC: 79996-300-16250mL NDC: 79996-300-17

250 ml NDC: 79996-300-17250 ml NDC: 79996-300-17

500 mL NDC: 79996-300-18

500 mL NDC: 79996-300-18500 mL NDC: 79996-300-18

1 L NDC: 79996-300-19

1000 mL NDC: 79996-300-191000 mL NDC: 79996-300-19

4000 mL NDC: 79996-300-20

4000 mL NDC: 79996-300-204000 mL NDC: 79996-300-20

20L NDC: 79996-300-21

20 L NDC: 79996-300-2120 L NDC: 79996-300-21

946.3 L NDC: 79996-300-14

946.3 L NDC: 79996-300-14946.3 L NDC: 79996-300-14

189.92 L NDC: 79996-300-13

189.92 L NDC: 79996-300-13189.92 L NDC: 79996-300-13

113.5 L NDC: 79996-300-12

113.5 L NDC: 79996-300-12113.5 L NDC: 79996-300-12

20 L NDC: 79996-300-11

20 L NDC: 79996-300-1120 L NDC: 79996-300-11

500 mL NDC: 79996-300-10

500 mL NDC: 79996-300-10500 mL NDC: 79996-300-10

300 mL NDC: 79996-300-09

300 mL NDC: 79996-300-09300 mL NDC: 79996-300-09

250 mL NDC: 79996-300-08

250 mL NDC: 79996-300-08250 mL NDC: 79996-300-08

120 mL NDC: 79996-300-07

120 mL NDC: 79996-300-07120 mL NDC: 79996-300-07

100 mL NDC: 79996-300-06

100 mL NDC: 79996-300-06100 mL NDC: 79996-300-06

60 mL NDC: 79996-300-05

60 mL NDC: 79996-300-0560 mL NDC: 79996-300-05

4000 mL NDC: 79996-300-04

4000 mL NDC: 79996-300-044000 mL NDC: 79996-300-04

1000 mL NDC: 79996-300-03

1000 mL NDC: 79996-300-031000 mL NDC: 79996-300-03

107 mL NDC: 79996-300-02

170 mL NDC: 79996-300-02170 mL NDC: 79996-300-02

52 mL NDC: 79996-300-01

52 mL NDC: 79996-300-0152 mL NDC: 79996-300-01

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79996-30079996-300-04, 79996-300-01, 79996-300-02, 79996-300-03, 79996-300-05, 79996-300-06, 79996-300-07, 79996-300-08, 79996-300-09, 79996-300-10, 79996-300-11, 79996-300-12, 79996-300-13, 79996-300-14, 79996-300-15, 79996-300-16, 79996-300-17, 79996-300-18, 79996-300-19, 79996-300-20, 79996-300-21, 79996-300-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT

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
43d1aa71-ec9e-3c22-e063-6294a90ad0d2adbc0ff8-d7c0-fc55-e053-2995a90a8be72023-12-04WarningsExact identifier
spl set id: adbc0ff8-d7c0-fc55-e053-2995a90a8be7

Reported adverse events (FAERS/openFDA)#

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