ANTIBACTERIAL BAR- 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 0.3%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on the skin

Warnings

For external use only.

Do not use

this product on infants under 6 months of age.

When using this product

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

Stop use and ask a doctor if

  • irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet bar with water
  • Lather vigorously and wash skin
  • Rinse and dry thoroughly

Other information

  • Protect from freezing and avoid excessive heat.

Inactive ingredients

Fragrance, Glycerin, PEG-6 Methyl Ether, Pentasodium Pentetate, Soap (Sodium Cocoate, Sodium Palmate), Sodium Chloride, Tetrasodium Etidronate, Water.

Package/Label Principal Display Panel

MedSpa Antibacterial Bar Soap box Principal Display panel

NDC 53329-048-68

MedSpa

antibacterial

bar soap

Contents: 200

NET WT. 1.25 oz (35 g) each

Box Left Panel

MedSpa Antibacterial Bar Soap box Left Panel

Box Right Panel

MedSpa Antibacterial Bar Soap box Right Panel

Box Back Panel and Top

MedSpa Antibacterial Bar Soap box Back Panel and Top
ANTIBACTERIAL BAR 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-048-68200 in 1 CARTON08/02/201012/31/2018
135 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/02/201012/31/2018
Labeler - Medline Industries, Inc. (025460908)

Revised: 5/2016
Document Id: 32a79fcc-a4ea-0b97-e054-00144ff8d46c
Set id: 69707ee6-8e92-4c0d-b162-024aa0c550a0
Version: 4
Effective Time: 20160512
 
Medline Industries, Inc.