ACTIVE GUARD- benzalkonium chloride liquid
HOME & BODY COMPANY

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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Active Guard Antibacterial Hand Soap 21.5 fl.oz

Active ingredient

0.13% Benzalkonium Chloride

Purpose

Antibacterial

Use

Helps reduce bacterial on hands

Warnings

For external use only.
When using this product do not use in or near the eyes.
In case of contact, rinse eyes throughly with water.

Keep out of reach of children

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or
contact a Poison Control Center right away.

Directions

Wash hands and rinse

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Lauramine Oxide, Cellulose Gum, DMDM Hydantoin, Polysorbate 20, Fragrance, Glycerin

Product label

new label

ACTIVE GUARD
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73746-018
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73746-018-01	636 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/05/2020	10/05/2022

Labeler - HOME & BODY COMPANY (081290720)

Registrant - HOME & BODY COMPANY (081290720)

Name	Address	ID/FEI	Business Operations
Establishment
HOME & BODY COMPANY		081290720	manufacture(73746-018)

Revised: 10/2022

Document Id: ea615934-8f5f-544d-e053-2995a90a81d9

Set id: a346bdac-8263-5e42-e053-2995a90a04e2

Version: 9

Effective Time: 20221006

HOME & BODY COMPANY