PRIMORY ANTIBACTERIAL PLUM FOAM HANDWASH- benzalkonium chloride liquid
GOJO Industries, Inc.

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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Primory Antibacterial Plum Foam Handwash

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), Propanediol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Fragrance (Parfum), Phenoxyethanol

Product Label

PRIMORY ANTIBACTERIAL PLUM FOAM HANDWASH
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-454
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
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)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21749-454-08	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/14/2017
2	NDC:21749-454-97	700 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/14/2017	12/31/2023
3	NDC:21749-454-89	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/14/2017
4	NDC:21749-454-90	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/14/2017

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-454)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	manufacture(21749-454) , label(21749-454) , pack(21749-454)