ADVOCATE HAND SANITIZER GEL- benzalkonium chloride gel
Enviro Specialty Chemicals Inc

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.

----------

ADVOCATE HAND SANITIZER GEL

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic/Hand & Skin Sanitizer

Uses:

Hand Sanitizer to help decrease bacteria on the skin.

Recommended for repeated use.

Directions:

Apply liberally to the palms of the hands. Rub into skin until dry.

Warnings:

Do not use in ears, eyes or mouth.

For external use only.

• When using this product, avoid contact with the eyes. In case of contact, flush eyes with water.

• Stop use and ask a doctor if redness or irritation develop.

• Children under 6 years of age should be supervised when using this product.

• Keep out of reach of children.

Other Information:

Store in a cool place below 104F° (40C°).

Inactive Ingredients:

Aloe Barbadensis leaf extract, Aqua, Citric Acid, Caprylyl Glucoside, Hydroxyethyl Cellulose,

Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.

Safe for Kids and Infants

ALCOHOL-FREE

FAST ACTING PROTECTION FROM GERMS

KILLS 99.99% OF GERMS

Formulated and enhanced with Zetrisil

WITH SOOTHING ALOE VERA

Distributed by:

Diabetic Supply of Suncoast, Inc.

PO Box 2102, Vega Alta, PR 00692

Toll-free: 1-866-373-2824

www.AdvocateMeters.com

Made in the USA

Packaging

ADVOCATE HAND SANITIZER GEL
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71884-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POLIHEXANIDE (UNII: 322U039GMF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71884-020-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020	12/09/2021
2	NDC:71884-020-08	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020	12/09/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/26/2020	12/09/2021

Labeler - Enviro Specialty Chemicals Inc (202621850)

Revised: 12/2021

Document Id: 17abcabc-0e0a-424e-9de8-b8022580c6ec

Set id: 156d8897-f77e-4438-bd0d-0c9fc6cba1a5

Version: 2

Effective Time: 20211209

Enviro Specialty Chemicals Inc