MEDSPA 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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047 Dignity Helth MedSpa Antibacterial Soap

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

Calcium Carbonate, Fragrance, Glycerine, Sodium Chloride, Sodium Palmate, Water.

Package/Label Principal Display Panel

DIGNITY HEALTH MEDSPA ANTIBACTERIAL SOAP PDP

MedSpa Antibacterial Bar Soap box Principal Display panel

NDC 53329-047-68

Dignity Health

MedSpa

Antibacterial soap

Contents: 200

NET WT. 0.75 oz (21 g)

REF DGN1006

Drug Facts and Side Panel

DIGNITY HEALTH MEDSPA ANTIBACTERIAL SOAP DRUG FACTS
MEDSPA ANTIBACTERIAL BAR 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-047
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PALMATE (UNII: S0A6004K3Z)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-047-73200 in 1 CARTON08/02/201008/01/2016
121 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 finalpart333E08/02/201008/01/2016
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou H&R Plastic Dailychemicall Co., Ltd.554455648manufacture(53329-047)

Revised: 12/2019
Document Id: 9a9db280-3c8c-7f44-e053-2995a90a08c5
Set id: 30fe749e-022d-4e6a-b730-629fb015ca07
Version: 2
Effective Time: 20191226
 
Medline Industries, Inc.