AQUAGEL ADVANCED FORMULA HAND SANITIZER- alcohol gel 
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.

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Active Ingredient(s)

Ethyl 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

water, aloe extract, Carbomer, Fragrance,glycerin, Triethanolamine

Package Label - Principal Display Panel

20L NDC:79996-050-07

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1L NDC:79996-050-03

f

4L NDC:79996-050-02

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52 mL NDC:79996-050-04

l

170 mL NDC:79996-050-01

170

50 Gallon NDC:79996-050-06 50250 Gallon NDC:79996-050-05

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Back Label for NDC:79996-050-01,79996-050-02,79996-050-03,79996-050-04,79996-050-05,79996-050-06,79996-050-07

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AQUAGEL ADVANCED FORMULA HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79996-050
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
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79996-050-01170 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
2NDC:79996-050-024000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
3NDC:79996-050-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
4NDC:79996-050-0452 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
5NDC:79996-050-05946300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
6NDC:79996-050-06189200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/30/2020
7NDC:79996-050-0720000 mL in 1 BOTTLE, DISPENSING; 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 - EPOXEMEX, S.A. de C.V. (814573127)
Establishment
NameAddressID/FEIBusiness Operations
EPOXEMEX, S.A. de C.V.814573127manufacture(79996-050)

Revised: 9/2020
Document Id: af861c38-3295-13fe-e053-2995a90a9932
Set id: af861c38-32a3-13fe-e053-2995a90a9932
Version: 1
Effective Time: 20200917
 
EPOXEMEX, S.A. de C.V.