ALCOHOL FREE HAND SANITIZER- benzalkonium chloride aerosol, foam

Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Free 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

Benzalkonoium Chloride 0.1%

Purpose

Antimicrobial

Uses

- For hand sanitizing to decrease the bacteria on 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 together briskly until dry

Inactive Ingredients:

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60933-200
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
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
UNDECETH-7 (UNII: R6B5PCO2JN)
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: 60933-200-00	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/2017

Labeler - Fuller Industries, LLC (078704329)

Establishment
Name	Address	ID/FEI	Business Operations
Fuller Industries, LLC		078704329	manufacture(60933-200)