AEROCLEAN HAND SANITIZER- alcohol gel 
Aerobal, 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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Aeroclean Alcohol 70%
NDC 61962-0010

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

Water, Glycerin, Rapidgel EZ1

Package Label - Principal Display Panel

60 mL NDC: 61962-0010-1

60 mL NDC: 61962-001-01 Front60 mL NDC: 61962-001-01 Back

180 mL NDC: 61962-0010-2

180 mL NDC: 61962-001-02

300 mL NDC: 61962-0010-3

300 mL NDC: 61962-001-03 Front300 mL NDC: 61962-001-03 Back

500 mL NDC: 61962-001-04

4000 mL NDC: 61962-0010-5

4000 mL NDC: 61962-001-05 Front4000 mL NDC: 61962-001-05 Back

5000 mL NDC: 61962-0010-6

5000 mL NDC: 61962-001-06 Front5000 mL NDC: 61962-001-06 Back

AEROCLEAN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61962-0010
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)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61962-0010-160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
2NDC:61962-0010-2180 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
3NDC:61962-0010-3300 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
4NDC:61962-0010-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
5NDC:61962-0010-54000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
6NDC:61962-0010-65000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/20/2020
Labeler - Aerobal, S.A. de C.V. (812833028)
Establishment
NameAddressID/FEIBusiness Operations
Aerobal, S.A. de C.V.812833028manufacture(61962-0010) , label(61962-0010) , pack(61962-0010)

Revised: 11/2020
Document Id: b554803a-08a4-4e02-e053-2a95a90a1185
Set id: b48b00af-cc95-0684-e053-2995a90a8e9b
Version: 2
Effective Time: 20201130
 
Aerobal, S.A. de C.V.