Inopak - Style 503

Inopak - Style 503

Drug Labeling and Warnings

Drug Details

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INODERM STYLE- parachlorometaxylenol liquid 
Inopak, Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Inopak - Style 503

Drug Facts
Active 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, gt 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, TEA-Lauryl 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, TEA-Lauryl 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

Inopak Style

Inopak Style

INODERM STYLE 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-503
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-503-011000 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2017
2NDC: 58575-503-023840 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
3NDC: 58575-503-08240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2017
4NDC: 58575-503-18540 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2017
5NDC: 58575-503-423785 mL in 1 JUG; Type 0: Not a Combination Product08/01/2017
6NDC: 58575-503-80800 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2017
7NDC: 58575-503-812000 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2017
Labeler - Inopak, Ltd (194718243)
Registrant - Inopak, Ltd (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd194718243manufacture(58575-503)

Revised: 10/2019
 
Inopak, Ltd


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