SIMPLE HYGIENE ALCOHOL FREE FOAM HAND SANITIZER- benzalkonium chloride liquid

Simple Hygiene Alcohol Free Foam Hand Sanitizer by

Drug Labeling and Warnings

Simple Hygiene Alcohol Free Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by FULLER INDUSTRIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands briskly together until dry.

Inactive Ingredients:

Water; Lauramine Oxide; Undeceth-7; DisodiumEDTA; DMDM Hydantoin; Fragrance; Citric Acid; FD&C Red #33; FD&C Blue #1.

Package Labeling:237ml

Package Labeling: 237ml 24 bottles

Package Labeling:1 gal

Package Labeling:1 gal 4 bottles

INGREDIENTS AND APPEARANCE

SIMPLE HYGIENE ALCOHOL FREE FOAM HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60933-018
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
UNDECETH-7 (UNII: R6B5PCO2JN)
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60933-018-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
2	NDC: 60933-018-02	24 in 1 BOX	08/01/2020
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 60933-018-03	3790 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2020
4	NDC: 60933-018-04	4 in 1 BOX	08/01/2020
4		3790 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/01/2020

Labeler - FULLER INDUSTRIES, INC (078704329)