PRIME SOURCE ANTIBACTERIAL FOAM HANDWASH- benzalkonium chloride liquid

PRIME SOURCE Antibacterial Foam Handwash by

Drug Labeling and Warnings

PRIME SOURCE Antibacterial Foam Handwash by is a Otc medication manufactured, distributed, or labeled by BUNZL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.5%

Purpose

Antimicrobial

Uses

Handwash to help decrease bacteria on the skin

Recommended for repeated use

Warnings

For external use only

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

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Wet hands

Apply a small amount of product and work into a lather

Rinse well and dry hands completely

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Fragrance (Parfum), Phenoxyethanol, Blue 1 (CI 42090), Red 33 (CI 17200)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIME SOURCE ANTIBACTERIAL FOAM HANDWASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66294-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.005 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
PEG-80 Sorbitan Laurate (UNII: 239B50Y732)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Ethylhexylglycerin (UNII: 147D247K3P)
Lauramine Oxide (UNII: 4F6FC4MI8W)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66294-400-23	700 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/30/2017
2	NDC: 66294-400-40	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/30/2017
3	NDC: 66294-400-42	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/30/2017

Labeler - BUNZL (799540588)