Life Quality Hand Sanitzer

Life Quality Hand Sanitzer by

Drug Labeling and Warnings

Life Quality Hand Sanitzer by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS ESME S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIFE QUALITY HAND SANITZER- alcohol gel 
LABORATORIOS ESME 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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Life Quality Hand Sanitzer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antibacterial

Uses

• Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts

Keep out of reach of children.

Do not swallow.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply a little quantity to the palm of the hand, rub until completely absorbed. Do not rinse.
• Children under 6 years of age should be supervised when using this product.

Other Information

• Clinically and Dermatologically Tested.
• *Without therapeutic action.
• *Escherichia coli - Psedomonas aeruginasa - Staphylococcus aureus - Bacillus subtilis - Candida albicans - Aspergyllius sp - Pencillium sp
• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine.

Package Labeling:65ml

Package Labeling:250ml

LIFE QUALITY HAND SANITZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81349-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81349-000-01	65 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021	03/01/2021
2	NDC: 81349-000-02	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2021	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2021	03/01/2021

Labeler - LABORATORIOS ESME S.A. (970057626)

Revised: 11/2022

Document Id: ec82b351-6b44-c060-e053-2a95a90a97a4

34390-5

Set id: b8654c18-8d16-5f36-e053-2a95a90ad84b

Version: 2

Effective Time: 20221102