AQUABAIN INSTANT HAND SANITIZER- ethyl alcohol 70% gel 
Industria La Popular, S.A.

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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Aquabain Instant Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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.

Directions

Other information

Inactive ingredients

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-50 Shea Butter, Aloe Barbadensis Extract, Aminomethyl Propanol

Package Label - Principal Display Panel

labellabel

AQUABAIN INSTANT HAND SANITIZER 
ethyl alcohol 70% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL91 mL  in 130 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
PEG-50 SHEA BUTTER (UNII: SF35CE4XLR)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62476-005-04130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
2NDC:62476-005-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - Industria La Popular, S.A. (846044576)
Registrant - Industria La Popular, S.A. (846044576)

Revised: 12/2021
Document Id: d3202743-4bda-792b-e053-2995a90a40d7
Set id: b2e4d58d-adff-3cb2-e053-2995a90a392e
Version: 2
Effective Time: 20211214
 
Industria La Popular, S.A.