AQUAGEL HAND SANITIZER- alcohol liquid 
EPOXEMEX, S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

AguaGel Hand Sanitizer misc

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. Glycerol
  3. Hydrogen peroxide
  4. Sterile distilled water or boiled cold water
  5. Aloe Vera Leaf Extract
  6. Fragance
  7. Triethanolamine.

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

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

Other information

Inactive ingredients

aloe vera leaf extract, fragance, glycerin, hydrogen peroxide, triethanolamine, purified water USP

Package Label - Principal Display Panel

20 L NDC: 79996-400-01

AQUA GEL LIQUID HAND SANITIZER 20 L

4 L NDC: 79996-400-02

AQUA GEL HAND SANITIZER 4 L

1 L NDC: 79996-400-03

AQUA GEL HAND SANITIZER 1 L

500 mL NDC: 79996-400-04

AQUA GEL LIQUID HAND SANITIZER 500 ml

250 mL NDC: 79996-400-05

AQUA GEL LIQUID HAND SANITIZER 250 mL

120 mL NDC: 79996-400-06

AQUA  GEL LIQUID HAND SANITIZER 120 ml

100 mL NDC: 79996-400-07

AQUA GEL LIQUID HAND SANITIZER 100 mL

60 mL NDC: 79996-400-08

AQUA GEL LIQUID HAND SANITIZER 60 ml

AQUAGEL HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79996-400
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79996-400-0120000 mL in 1 TANK; Type 0: Not a Combination Product03/30/2020
2NDC:79996-400-024000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:79996-400-031000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:79996-400-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:79996-400-05250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
6NDC:79996-400-06120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
7NDC:79996-400-07100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
8NDC:79996-400-0860 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
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(79996-400)

Revised: 6/2022
Document Id: e2b23bc8-5f75-adf8-e053-2a95a90aca8e
Set id: b4b7c64a-56ba-fc66-e053-2a95a90a137c
Version: 3
Effective Time: 20220630
 
EPOXEMEX, S.A. DE C.V.