AQUAGEL ADVANCED FORMULA- hand sanitizer gel

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]

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)

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

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 or rash 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

• 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

60 mL NDC: 79996-300-15

120 ml NDC: 79996-300-16

250mL NDC: 79996-300-17

500 mL NDC: 79996-300-18

1 L NDC: 79996-300-19

4000 mL NDC: 79996-300-20

20L NDC: 79996-300-21

946.3 L NDC: 79996-300-14

189.92 L NDC: 79996-300-13

113.5 L NDC: 79996-300-12

20 L NDC: 79996-300-11

500 mL NDC: 79996-300-10

300 mL NDC: 79996-300-09

250 mL NDC: 79996-300-08

120 mL NDC: 79996-300-07

100 mL NDC: 79996-300-06

60 mL NDC: 79996-300-05

4000 mL NDC: 79996-300-04

1000 mL NDC: 79996-300-03

107 mL NDC: 79996-300-02

52 mL NDC: 79996-300-01

INGREDIENTS AND APPEARANCE

AQUAGEL ADVANCED FORMULA 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79996-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79996-300-04	4000 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020	12/31/2021
2	NDC: 79996-300-01	52 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
3	NDC: 79996-300-02	170 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
4	NDC: 79996-300-03	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
5	NDC: 79996-300-05	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
6	NDC: 79996-300-06	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
7	NDC: 79996-300-07	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
8	NDC: 79996-300-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
9	NDC: 79996-300-09	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
10	NDC: 79996-300-10	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	12/31/2021
11	NDC: 79996-300-11	20000 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020	12/31/2021
12	NDC: 79996-300-12	113500 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020	12/31/2021
13	NDC: 79996-300-13	189920 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020	12/31/2021
14	NDC: 79996-300-14	946300 mL in 1 TANK; Type 0: Not a Combination Product	03/30/2020	12/31/2021
15	NDC: 79996-300-15	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021
16	NDC: 79996-300-16	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
17	NDC: 79996-300-17	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021
18	NDC: 79996-300-18	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021
19	NDC: 79996-300-19	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2021
20	NDC: 79996-300-20	4000 mL in 1 TANK; Type 0: Not a Combination Product	12/30/2021
21	NDC: 79996-300-21	20000 mL in 1 TANK; Type 0: Not a Combination Product	12/30/2021
22	NDC: 79996-300-22	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2023

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(79996-300)