GLS-570 HAND SANITIZER- alcohol gel
GDI Services (Canada) LP

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.

----------

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

Hand sanitizer, health care personnel hand rub 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

on children less than 2 years 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 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 59-86 F (15-30 C)

Avoid freezing and excessive heat above 104 F (40 C)

Inactive ingredients

purified water, glycerin, carbomer, aloe barbadensis leaf extract, tocopheryl acetate,triethanolamine

SANY+

GLS-570

Gel Hand Sanitizer

Alcohol

Antiseptic 70%

Topical Non-Sterile

Solution

Antiseptic

Hand Rub

Net 33.6 FLOZ (1 L)

Antiseptic

container label

GLS-570 HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80754-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80754-001-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2020
2	NDC:80754-001-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/22/2020

Labeler - GDI Services (Canada) LP (201810822)

Name	Address	ID/FEI	Business Operations
Establishment
Les Enterprises Stefmar Inc		240496385	manufacture(80754-001)

Revised: 12/2022

Document Id: f02f8143-3237-7ca7-e053-2995a90a3844

Set id: b4b65151-199c-fda2-e053-2995a90a75cb

Version: 3

Effective Time: 20221219

GDI Services (Canada) LP