Antibacterial Hand Cleanser Gel, Non-alcohol

ANTIBACTERIAL HAND CLEANSER, NON-ALCOHOL- benzalkonium chloride gel
Beacon Promotions

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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Drug Facts:

Active Ingredient, Benzalkonium Chloride 0.10%

Purpose:

Antiseptic

Use: For handwashing to decrease bacteria on skin.

Warning: For external use only. Do not use in the eyes. If contact occurs, flush with water. Call a doctor

Stop use and ask a doctor if irritation and redness develop

keep out of reach of children

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Do not store above 100degrees F (43degrees C)

Deionized water, Propylene Glycol, Glycerin Carbomer, Triethanolamine, and Fragrance

HC104AB Made in China

Distributed by Beacon Promotions, Inc.

(507) 233-3278

Lot No.

Antibacterial Hand Cleanser Gel

ANTIBACTERIAL HAND CLEANSER, NON-ALCOHOL
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75866-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.0 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description
Packaging
1	NDC:75866-001-05	5 mL in 1 BOTTLE
2	NDC:75866-001-10	10 mL in 1 BOTTLE
3	NDC:75866-001-20	20 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/29/2010

Labeler - Beacon Promotions (136344053)