Search by Drug Name or NDC

NDC 42584-0400-01 RENOWN Antibacterial Plum Handwash 0.005 mg/mL Details

RENOWN Antibacterial Plum Handwash 0.005 mg/mL

RENOWN Antibacterial Plum Handwash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Home Depot U.S.A., Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	42584-0400
Product ID	42584-0400_cde76bf7-9a4a-4b90-9bac-89937478e5b2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	RENOWN Antibacterial Plum Handwash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.005
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Home Depot U.S.A., Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42584-0400-01 (42584040001)

Pricing Information	N/A
NDC Package Code	42584-0400-1
Billing NDC	42584040001
Package	1200 mL in 1 PACKAGE (42584-0400-1)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b577c676-10d0-4b4a-ace8-4e21a771929d Details

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

RENOWN ANTIBACTERIAL PLUM HANDWASH

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42584-0400
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42584-0400-7	700 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2020
2	NDC:42584-0400-1	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2020
3	NDC:42584-0400-5	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/01/2019

Labeler - Home Depot U.S.A., Inc. (783266950)

Revised: 12/2020

Document Id: cde76bf7-9a4a-4b90-9bac-89937478e5b2

Set id: b577c676-10d0-4b4a-ace8-4e21a771929d

Version: 1

Effective Time: 20201223