SKINTEGRITY ANTIBACTERIAL HAND BLUE- 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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Drug Facts

Active ingredient

Triclosan 0.5%

Purpose

Antiseptic Handwash

Uses

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

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7, DMDM Hydantoin, BHT, Fragrance, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid, Blue 1.

Package/Label Principal Display Panel

Skintegrity Antibacterial Hand Soap bag label

Skintegrity Antibacterial Hand Soap bag label

NDC 53329-043-20

skintegrity

antibacterial hand soap

27 fl oz (800 mL)

Package Box Label - Back and Side

Skintegrity Antibacterial Hand Soap box, back and side

Skintegrity Antibacterial Hand Soap box, back and side

Package Box Label - Front and side

Skintegrity Antibacterial Hand Soap box, front and side

Skintegrity Antibacterial Hand Soap box, front and side

SKINTEGRITY ANTIBACTERIAL HAND  BLUE
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.5 mL  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; 1600 KD) (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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-043-201 in 1 BOX
1800 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/08/2011
Labeler - Medline Industries, Inc. (025460908)

Revised: 7/2011
Document Id: f8366a24-06ac-4417-a1fc-ea7338a0781d
Set id: f8366a24-06ac-4417-a1fc-ea7338a0781d
Version: 3
Effective Time: 20110713
 
Medline Industries, Inc.