AlcoSoft Antibacterial Hand Sanitizer

AlcoSoft Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

AlcoSoft Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by AromaQuest Systems, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOSOFT ANTIBACTERIAL HAND SANITIZER- alcohol gel 
AromaQuest Systems, LLC.

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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AlcoSoft Antibacterial Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antibacterial

Uses

Hand rub to help reduce bacteria that potencially can cause disease.

Warning

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 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

  • 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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water, carbomer, triisopropanolamine.

Package Labeling:1000ml

Label

Package Labeling:240ml

Label2

Package Labeling:3785ml

Label3

Package Labeling:475ml

Label4

ALCOSOFT ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79765-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79765-002-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/202012/31/2021
2NDC: 79765-002-02240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/202012/31/2021
3NDC: 79765-002-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/202012/31/2021
4NDC: 79765-002-04475 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/14/202012/31/2021
Labeler - AromaQuest Systems, LLC. (080914413)

Revised: 12/2021
Document Id: d3992149-2810-33d4-e053-2a95a90a74f7
Set id: acaea066-0b1c-7d8f-e053-2995a90abf7f
Version: 2
Effective Time: 20211220