INODERM STYLE ANTIBACTERIAL- chloroxylenol liquid

INODERM Style Antibacterial by

Drug Labeling and Warnings

INODERM Style Antibacterial by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Chloroxylenol 0.3% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• For handwashing to help reduce bacteria on the skin.
• Recommended for repeat use.

WARNINGS

Warnings

For external use only.

When using this product, keep away from eyes. In case of eye contact, flush 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.
• Lather vigorously for at least 15 seconds.
• Rinse with 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.

SPL UNCLASSIFIED SECTION

Inopak, LTD.

Ringwood, NJ 07456

1-800-762-7725 www.inopak.com

PRINCIPAL DISPLAY PANEL

INODERM®

With Moisturizers

Style

Contains Chloroxylenol 0.3%

Liquid Antibacterial Soap

18 fl. oz. (532 mL)

INGREDIENTS AND APPEARANCE

INODERM STYLE ANTIBACTERIAL 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-523
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-523-42	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2021	07/22/2024
2	NDC: 58575-523-07	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2021	10/08/2023
3	NDC: 58575-523-17	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2021	07/19/2024
4	NDC: 58575-523-80	1 in 1 BOX	04/20/2021	01/28/2024
4		800 mL in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 58575-523-82	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/20/2021	04/21/2024
6	NDC: 58575-523-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/20/2021	11/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/20/2021	07/22/2024

Labeler - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-523)