AQUAGEL ADVANCED FORMULA by EPOXEMEX, S.A DE C.V. / AY CONSULTING SERVICES, LLC / EPOXEMEX, S.A. DE C.V.

AQUAGEL ADVANCED FORMULA by

Drug Labeling and Warnings

AQUAGEL ADVANCED FORMULA by is a Otc medication manufactured, distributed, or labeled by EPOXEMEX, S.A DE C.V., AY CONSULTING SERVICES, LLC, EPOXEMEX, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AQUAGEL ADVANCED FORMULA- hand sanitizer gel 
EPOXEMEX, S.A DE C.V.

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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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

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

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 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.

Directions

  • 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

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

Inactive ingredients

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

Package Label - Principal Display Panel

100 mL NDC: 79996-300-22

NDC: <a href=/NDC/79996-300-22>79996-300-22</a> 100 mL

60 mL NDC: 79996-300-15

60 ml NDC: <a href=/NDC/79868-300-15>79868-300-15</a>

120 ml NDC: 79996-300-16

120 mL NDC: <a href=/NDC/79996-300-16>79996-300-16</a>250mL NDC: 79996-300-17

250 ml NDC: <a href=/NDC/79996-300-17>79996-300-17</a>

500 mL NDC: 79996-300-18

500 mL NDC: <a href=/NDC/79996-300-18>79996-300-18</a>

1 L NDC: 79996-300-19

1000 mL NDC: <a href=/NDC/79996-300-19>79996-300-19</a>

4000 mL NDC: 79996-300-20

4000 mL NDC: <a href=/NDC/79996-300-20>79996-300-20</a>

20L NDC: 79996-300-21

20 L NDC: <a href=/NDC/79996-300-21>79996-300-21</a>

946.3 L NDC: 79996-300-14

946.3 L NDC: <a href=/NDC/79996-300-14>79996-300-14</a>

189.92 L NDC: 79996-300-13

189.92 L NDC: <a href=/NDC/79996-300-13>79996-300-13</a>

113.5 L NDC: 79996-300-12

113.5 L NDC: <a href=/NDC/79996-300-12>79996-300-12</a>

20 L NDC: 79996-300-11

20 L NDC: <a href=/NDC/79996-300-11>79996-300-11</a>

500 mL NDC: 79996-300-10

500 mL NDC: <a href=/NDC/79996-300-10>79996-300-10</a>

300 mL NDC: 79996-300-09

300 mL NDC: <a href=/NDC/79996-300-09>79996-300-09</a>

250 mL NDC: 79996-300-08

250 mL NDC: <a href=/NDC/79996-300-08>79996-300-08</a>

120 mL NDC: 79996-300-07

120 mL NDC: <a href=/NDC/79996-300-07>79996-300-07</a>

100 mL NDC: 79996-300-06

100 mL NDC: <a href=/NDC/79996-300-06>79996-300-06</a>

60 mL NDC: 79996-300-05

60 mL NDC: <a href=/NDC/79996-300-05>79996-300-05</a>

4000 mL NDC: 79996-300-04

4000 mL NDC: <a href=/NDC/79996-300-04>79996-300-04</a>

1000 mL NDC: 79996-300-03

1000 mL NDC: <a href=/NDC/79996-300-03>79996-300-03</a>

107 mL NDC: 79996-300-02

170 mL NDC: <a href=/NDC/79996-300-02>79996-300-02</a>

52 mL NDC: 79996-300-01

52 mL NDC: <a href=/NDC/79996-300-01>79996-300-01</a>

AQUAGEL ADVANCED FORMULA 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79996-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79996-300-044000 mL in 1 TANK; Type 0: Not a Combination Product03/30/202012/31/2021
2NDC: 79996-300-0152 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
3NDC: 79996-300-02170 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
4NDC: 79996-300-031000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
5NDC: 79996-300-0560 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
6NDC: 79996-300-06100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
7NDC: 79996-300-07120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
8NDC: 79996-300-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
9NDC: 79996-300-09300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
10NDC: 79996-300-10500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/202012/31/2021
11NDC: 79996-300-1120000 mL in 1 TANK; Type 0: Not a Combination Product03/30/202012/31/2021
12NDC: 79996-300-12113500 mL in 1 TANK; Type 0: Not a Combination Product03/30/202012/31/2021
13NDC: 79996-300-13189920 mL in 1 TANK; Type 0: Not a Combination Product03/30/202012/31/2021
14NDC: 79996-300-14946300 mL in 1 TANK; Type 0: Not a Combination Product03/30/202012/31/2021
15NDC: 79996-300-1560 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2021
16NDC: 79996-300-16120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
17NDC: 79996-300-17250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2021
18NDC: 79996-300-18500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2021
19NDC: 79996-300-191000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2021
20NDC: 79996-300-204000 mL in 1 TANK; Type 0: Not a Combination Product12/30/2021
21NDC: 79996-300-2120000 mL in 1 TANK; Type 0: Not a Combination Product12/30/2021
22NDC: 79996-300-22100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00303/30/202012/03/2024
Labeler - EPOXEMEX, S.A DE C.V. (814573127)
Registrant - AY CONSULTING SERVICES, LLC (078311971)
Establishment
NameAddressID/FEIBusiness Operations
EPOXEMEX, S.A. DE C.V.814573127manufacture(79996-300)

Revised: 12/2024
Document Id: 286263ae-15cb-2d83-e063-6394a90a5f57
Set id: adbc0ff8-d7c0-fc55-e053-2995a90a8be7
Version: 7
Effective Time: 20241203
 
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