INODERM STYLE- parachlorometaxylenol liquid

INODERM Style by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug FactsActive Ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Uses

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

Warnings

• For external use only.
• Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
• Stop use and ask a doctor if irritation and 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.

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 Ingredients

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

Questions?

Call 1-800-767-7725 or visit our wedsite www.inopak.com

INODERM® Style - product label

INODERM®			Rev. 1.02 5031-430-02	Drug Facts Active Ingredient                                      Purpose Parachlorometaxylenol 0.3% w/w……. Antiseptic Uses Handwash to help reduce bacteria on the skin that    potentially can cause disease. Recommended for repeated use. Warnings For external use only. Keep out of eyes, ears, or mouth. In case of eye     contact, flush eyes with water. Keep out of reach of children. If swallowed, get    medical help or contact a Poison Control Center    right away. 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 ingredients Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water
		With Moisturizers
Style Liquid Antibacterial Soap
18 oz. (532 mL)			INOPAK
MADE    IN THE	USA	Inopak, LTD.  Ringwood, NJ 07456 1-800-762-7725 www.inopak.com
				5031-430-DF	Rev. 1.02

Style Case

Style Liquid Antibacterial Soap                 5031-CS  Rev. 1.0

O   24/8 Bottles                               O   16/18 oz Bottles                       O  4/1 gal Bottles                           

       5031-440-02                                  5031-430-02                               5031-420-02                                 

    040232 65068 0                             040232 65067 3                          040232 65097 0                                         

O   8/1000 ml Disc Pumps           O   12/800 ml Pouches                 O  4/2000 Disc Pumps                 

       5031-L1000                              5031-404                                   5031-XL2000                                              

       04023265066 6                        040232 65064 2                          040232 65065 9               

MADE

IN THE USA         Inopak, LTD.       Ringwood, NJ 07456        1-800-762-7725 www.inopak.com        INOPAK

Style 800ml case

INODERM®                              5031-403-01

5031-403-01 CS                                 Rev. 1.0

Style                      Press Pak®

Liquid Antibacterial Soap

12/800ml MADE IN THE USA       INOPAK

                                                                Inopak, LTD.       Ringwood, NJ 07456

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

INGREDIENTS AND APPEARANCE

INODERM STYLE 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.003 mg  in 1 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. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-503-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2017
2	NDC: 58575-503-02	3840 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017
3	NDC: 58575-503-08	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2017
4	NDC: 58575-503-18	540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2017
5	NDC: 58575-503-42	3785 mL in 1 JUG; Type 0: Not a Combination Product	08/01/2017
6	NDC: 58575-503-80	800 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2017
7	NDC: 58575-503-81	2000 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2017

Labeler - Inopak, Ltd (194718243)

Registrant - Inopak, Ltd (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd		194718243	manufacture(58575-503)