Skintegrity by Medline Industries, Inc. Drug Facts

Skintegrity by

Drug Labeling and Warnings

Skintegrity by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKINTEGRITY FOAMING- chloroxylenol soap 
Medline Industries, Inc.

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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Drug Facts

Active ingredient

Chloroxylenol (PCMX) 0.3%

Purpose

Antiseptic Handwash

Uses

  • for handwashing to decrease bacteria on the skin

Warnings

For external use only.

  • Avoid contact with eyes. If contact occurs, flush with water
  • Stop use and ask a doctor, if redness or irritation develops and 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

  • apply a small amount, covering hands with product for 30 seconds.
  • add water, lather and rinse.

Inactive ingredients

Aloe Barbadensis Leaf, Comcamide DIPA, Coconut Acid, Fragrance, Iodopropynyl Butylcarbamate, Phenoxyethanol, Potassium Hydroxide, Red 33, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Sodium Sulfate, Tall Oil Acid, Tetrasodium EDTA, Tocopheryl Acetate, Water, Yellow 5

Package/Label Principal Display Panel

Medline Skintegrity Antibacterial Hand Soap PDP and Drug Facts

MEDLINE

NDC: 53329-979-84

Skintegrity

Professional Hand Hygiene

antibacterial hand soap

33.8 fl oz (1000 mL)

SKINTEGRITY  FOAMING
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-979
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.33 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
COCONUT ACID (UNII: 40U37V505D)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
TALL OIL ACID (UNII: H9HR63474M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-979-841000 mL in 1 BAG; Type 0: Not a Combination Product02/12/201510/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/12/201510/23/2017
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2019
Document Id: 98427313-d4cf-15ca-e053-2995a90a980c
Set id: 774f14c6-aee7-4031-9223-0397ea31a47c
Version: 2
Effective Time: 20191126
 
Medline Industries, Inc.