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Skintegrity Antibacterial Hand Foaming

Dosage form: soap
Ingredients: TRICLOSAN 0.5mL in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-978

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.

Drug Facts

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

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Glycerin, Polyquaternium-7, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, DMDM Hydantoin, Fragrance, Tetrasodium EDTA, Polyquaternium-10, Aloe Barbadensis Leaf, Tocopheryl Acetate, Citric Acid, Red 33, Yellow 5.

Package/Label Principal Display Panel

MEDLINE

NDC 53329-978-82

skintegrity

antibacterial hand soap

1.7 fl oz (50 mL)

SKINTEGRITY ANTIBACTERIAL HAND  FOAMING
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-978
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM LAURYL SULFATE 
SODIUM LAURETH SULFATE 
GLYCERIN 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
COCO DIETHANOLAMIDE 
DMDM HYDANTOIN 
EDETATE SODIUM 
POLYQUATERNIUM-10 (400 CPS AT 2%) 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, D- 
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:53329-978-841000 mL in 1 BAG
2NDC:53329-978-8250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/08/2011
Labeler - Medline Industries, Inc. (025460908)

Revised: 08/2011
Document Id: 8c01bcd8-6beb-4940-b5b3-02c3dec43cc1
Set id: 8c01bcd8-6beb-4940-b5b3-02c3dec43cc1
Version: 1
Effective Time: 20110808
 
Medline Industries, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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