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Skintegrity Antibacterial Hand Amber

Medically reviewed on October 2, 2017

Dosage form: soap
Ingredients: TRICLOSAN 0.5mL in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-018

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
  • 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

MEDLINE

NDC 53329-018-04

skintegrity

antibacterial hand soap

4 fl oz (118 mL)

SKINTEGRITY ANTIBACTERIAL HAND  AMBER
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-018
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 
SODIUM CHLORIDE 
COCO DIETHANOLAMIDE 
GLYCERIN 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
DMDM HYDANTOIN 
BUTYLATED HYDROXYTOLUENE 
CITRIC ACID MONOHYDRATE 
EDETATE SODIUM 
GLUTAMIC ACID 
LEUCINE 
SERINE 
PHENYLALANINE 
PROLINE 
GLYCINE 
VALINE 
ISOLEUCINE 
ARGININE 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:53329-018-201 BAG in 1 BOX
1800 mL in 1 BAG
2NDC:53329-018-841 BAG in 1 BOX
21000 mL in 1 BAG
3NDC:53329-018-04118 mL in 1 BOTTLE
4NDC:53329-018-08221 mL in 1 BOTTLE, PUMP
5NDC:53329-018-06473 mL in 1 BOTTLE, PUMP
6NDC:53329-018-253785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/08/2011
Labeler - Medline Industries, Inc. (025460908)

 
Medline Industries, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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