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NDC 42584-0081-02 RENOWN Antibacterial Foam Cleanser 0.3 mg/100mL Details

RENOWN Antibacterial Foam Cleanser 0.3 mg/100mL

RENOWN Antibacterial Foam Cleanser 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 CHLOROXYLENOL.

Product Information

NDC	42584-0081
Product ID	42584-0081_5967c112-aa66-4364-b62e-b225847054b9
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 Foam Cleanser
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chloroxylenol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.3
Active Ingredient Units	mg/100mL
Substance Name	CHLOROXYLENOL
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 42584-0081-02 (42584008102)

Pricing Information	N/A
NDC Package Code	42584-0081-2
Billing NDC	42584008102
Package	2000 mL in 1 PACKAGE (42584-0081-2)
Marketing Start Date	2020-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 92519aab-a974-4169-b88a-00adf1ce9474 Details

Active ingredient

Chloroxylenol 0.3%

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), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RENOWN ANTIBACTERIAL FOAM CLEANSER

chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42584-0081
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTIC ACID (UNII: 33X04XA5AT)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
JOJOBA OIL (UNII: 724GKU717M)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CORN OIL (UNII: 8470G57WFM)
AMMONIUM SULFATE (UNII: SU46BAM238)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42584-0081-5	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/01/2020
2	NDC:42584-0081-2	2000 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2020

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

Revised: 12/2020

Document Id: 5967c112-aa66-4364-b62e-b225847054b9

Set id: 92519aab-a974-4169-b88a-00adf1ce9474

Version: 1

Effective Time: 20201223