SKINTEGRITY ANTIBACTERIAL HAND CLEAR- triclosan 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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019 Skintegrity Antibacterial Hand Soap (clear)

Active ingredient

Triclosan 0.5%

Purpose

Antiseptic Handwash

Uses

  • for handwashing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

  • avoid contact with eyes. In case of eye contact, immediately flush with water.

Stop use and ask a doctor if

  • irritation or redness develop
  • 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

  • pump into wet hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7, DMDM Hydantoin, BHT, Fragrance, Citric Acid, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid, Yellow 5, Red 33.

Package/Label Principal Display Panel

Skintegrity antibacterial hand soap label

MEDLINE

NDC 53329-019-84

skintegrity

antibacterial hand soap

33.8 fl oz (1000 mL)

SKINTEGRITY ANTIBACTERIAL HAND  CLEAR
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
LEUCINE (UNII: GMW67QNF9C)  
SERINE (UNII: 452VLY9402)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
PROLINE (UNII: 9DLQ4CIU6V)  
GLYCINE (UNII: TE7660XO1C)  
VALINE (UNII: HG18B9YRS7)  
ISOLEUCINE (UNII: 04Y7590D77)  
ARGININE (UNII: 94ZLA3W45F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-019-841000 mL in 1 BAG; Type 0: Not a Combination Product08/01/201212/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/201212/31/2018
Labeler - Medline Industries, Inc. (025460908)

Revised: 12/2019
Document Id: 9ab0dbff-3fda-333f-e053-2a95a90a2c9b
Set id: 85c8bff9-8286-4c6f-9eb7-547b16c59f30
Version: 3
Effective Time: 20191227
 
Medline Industries, Inc.