ABBEXA HAND SANITIZER- ethanol gel 
ABBEXA LTD

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.

----------

Abbexa Hand Sanitizer Gel

Product Information

Active Ingredient

Ethanol 75%

Purpose

Antiseptic

Use To sterilize and disinfect skin.

Warnings For external use only.

FLAMMABLE liquid and vapour. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Causes serious eye irritation. Keep container tightly closed.

Avoid contact with eyes. If contact occurs, immediately rinse eyes with water. Stop use and consult a doctor if irritation and redness persists.

Keep out of reach of children. If swallowed, seek medical assistance.

Directions Apply evenly to hands, then repeatedly rub hands until product has dried. No water required. Do not use on damaged, sensitive or irritated skin. In case of contact, rinse thoroughly with tepid water.

Other Information Proven to be effective at decreasing bacteria. Suitable for repeated use on skin.

This product contains ethanol, which can irritate mucous membranes and wounds, and should not be used by those who are allergic to alcohol.

Storage Do not store above 110°F (43 °C).

Inactive Ingredients Carbomer, Glycerol, Rose Essence, Distilled Water, Triethanolamine.

Rinse-Free

Quick Drying

Antibacterial

Abbexa LTD, Cambridge, UK, CB4 0GJ

T: +44 1223 755950
Abbexa LLC, Houston, TX, USA, 77042
T: +1 832 327 7413

Packaging

image description

ABBEXA HAND SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74029-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74029-100-01100 mL in 1 TUBE; Type 0: Not a Combination Product04/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/02/2020
Labeler - ABBEXA LTD (219351130)
Establishment
NameAddressID/FEIBusiness Operations
ABBEXA LTD219351130manufacture(74029-100)

Revised: 4/2020
Document Id: 5de75d89-f172-42d1-a81b-065146cc08fe
Set id: a9f31fd3-2b17-4b44-8bf0-2d4ee8d52a17
Version: 1
Effective Time: 20200402
 
ABBEXA LTD