Active Ingredient

Benzalkonium Chloride 0.15%(w/w)

Purpose

Anitbacterial

Handwash to help decrease bacteria on the skin

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

Stop use if, in rare instances, redness or irrtiation develops. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, and rinse.

water, sorbitol, glycerine, decyl glucoside, dmdm hydantoin, fragrance.

3.78 L NDC: 75009-103-01

3787g label

18.92 L NDC: 75009-103-02

18933g label

208.19 L NDC: 75009-103-03

208269g label

1040.98 L NDC: 75009-103-04

1041556g label

FOAM 103
antibacterial foaming soap soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.15 g in 100 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75009-103-01	3787 g in 1 JUG; Type 0: Not a Combination Product	05/25/2020
2	NDC:75009-103-02	18933 g in 1 PAIL; Type 0: Not a Combination Product	05/25/2020
3	NDC:75009-103-03	208269 g in 1 DRUM; Type 0: Not a Combination Product	05/25/2020
4	NDC:75009-103-04	1041556 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/25/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/25/2020

Labeler - Alpha Aromatics (041723545)

Name	Address	ID/FEI	Business Operations
Establishment
Alpha Aromatics		041723545	manufacture(75009-103)