ECCO Antiseptic Hand Gel: Package Insert and Label Information

ECCO ANTISEPTIC HAND GEL- alcohol gel
LUXFARMOL, SOCIETATEA CU RASPUNDERE LIMITATA

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.

Drug Facts

Active Ingredient

Ethyl alcohol (75% v/v)

Purpose

Antibacterial

Uses

kill germs and remove dirt

Warnings

For external use only

Dont use

if you are allergic to any of the any of ingredients

When using this product

do not get into eyes. If contact occurs, wash thoroughly with water

Stop use and ask doctor

if irritation or rash develops and continuous for more than 72 hours

Keep out of reach of children

Directions

• Adults and children 3 years and over
• Children under 3 years ask a doctor before use

Inactive ingredients:

Purified water, Glycerin, perfume, Ammonium Acryloyldimethyltaurate/ VP Copolymer.

Package Labeling:

ECCO ANTISEPTIC HAND GEL alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79164-000 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79164-000-00 200 TUBE in 1 BOX contains a TUBE 1 3 mL in 1 TUBE This package is contained within the BOX (79164-000-00)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/10/2021

Labeler — LUXFARMOL, SOCIETATEA CU RASPUNDERE LIMITATA (535199494)

Establishment
Name	Address	ID/FEI	Operations
LUXFARMOL, SOCIETATEA CU RASPUNDERE LIMITATA		535199494	manufacture (79164-000)

Revised: 02/2021 LUXFARMOL, SOCIETATEA CU RASPUNDERE LIMITATA