NOVO PROSERIES ANTIBACTERIAL FOAMING- chloroxylenol liquid

Novo ProSeries Antibacterial by

Drug Labeling and Warnings

Novo ProSeries Antibacterial by is a Otc medication manufactured, distributed, or labeled by Noble Chemical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Chloroxylenol 0.3% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• Handwash to help reduce bacteria on the skin that can potentially cause disease.
• Recommended for repeated use.

WARNINGS

Warnings

For external use only.

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.

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

DOSAGE & ADMINISTRATION

Directions

• Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
• Wash both hands thoroughly for 15 seconds.
• Rinse under running water and dry thoroughly.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, DMDM Hydantoin, Alcohol, Fragrance, Isopropyl Alcohol, Citric Acid, FD&C Yellow 5, FD&C Red 4.

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Distributed by:

Noble Chemical, Inc.

2205 Old Philadelphia Pike

Lancaster, PA 17602

PRINCIPAL DISPLAY PANEL

novo ProSeries

Antibacterial Foaming Hand Soap

Choroxylenol 0.3%

ocean breeze scented

1000mL (33.8 FL. OZ.)

INGREDIENTS AND APPEARANCE

NOVO PROSERIES ANTIBACTERIAL  FOAMING
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81551-063
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81551-063-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	04/27/2021	06/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/27/2021	06/14/2024

Labeler - Noble Chemical (170348663)