OTC Medication Information: Pro Advantage Antibacterial

PRO ADVANTAGE ANTIBACTERIAL- triclosan liquid
NDC National Distribution & Contracting, 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.

Pro Advantage Antibacterial Liquid Soap

Active Ingredient

Triclosan, 0.3%

Purpose

Antiseptic Handwash

Use

Handwash to help reduce bacteria that potentially can cause disease.

Warnings

• For external use only

Ask a doctor before use if you have

• Deep wounds, animals bites, or serious burns.

When using this product

• Avoid contact with eyes. If this occurs, rinse thoroughly with water.

Stop use and ask a doctor if

• Irritation, itching or redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Directions

Wet hands, apply soap, lather for 30 seconds, and rinse hands thoroughly.

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamine Oxide, Sodium Chloride, Cocamidopropyl Betaine, Propylene Glycol, DMDM Hydantoin, Fragrance, FDandC Yellow 5, FDandC Red 40

REF: P778128 NDC 43128-108-03

Made in China
www.ProAdvantagebyNDC.com
Manufactured for NDC, Inc.
407 New Sanford Road, La Vergne, TN 37086

Product Label

AntibacterialLiquidSoap
(click image for full-size original)

PRO ADVANTAGE ANTIBACTERIAL
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43128-128
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 3 mg in 0.001 L
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURETH-3 SULFATE
COCAMINE OXIDE
SODIUM CHLORIDE
COCAMIDOPROPYL BETAINE
PROPYLENE GLYCOL
DMDM HYDANTOIN
FD&C YELLOW NO. 5
FD&C RED NO. 40
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43128-128-03 3.8 L in 1 JUG None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/24/2013
Labeler — NDC National Distribution & Contracting, Inc. (009831413)
Establishment
Name Address ID/FEI Operations
Dukal 088520668 manufacture (43128-128)

Revised: 03/2023 NDC National Distribution & Contracting, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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