NeoStrata Antibacterial Facial Cleanser

Dosage form: liquid
Ingredients: TRICLOSAN 3mg in 1mL
Labeler: NeoStrata Company Inc
NDC Code: 58414-8321

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.

NeoStrata®
Antibacterial
Facial
Cleanser

Drug Facts

Active Ingredient

Triclosan 0.3%

Purpose

Antibacterial

Uses

Reduces potentially problematic bacteria on the skin

Warnings

For external use only

Do not apply to broken or inflamed skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if skin irritation develops and becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions
  • Apply to wet skin and gently massage to develop foaming action
  • Rinse thoroughly with water
  • Use twice daily

Other Information
  • Store at 15°C-30°C (59°F-86°F)
  • You may report serious side effects to 1-800-628-9904

Inactive Ingredients

Ammonium Chloride, Ammonium Laureth Sulfate, Anthemis Noblis (Chamomile) Flower Extract, Aqua (Water), Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Gluconolactone, Glycine, Lauryl Alcohol, Methylparaben, Panthenol, PEG-80 Sorbitan Laurate, Phenoxyethanol, Polyquaternium-10, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Triethanolamine.

PRINCIPAL DISPLAY PANEL - 177ml Carton

NeoStrata®

REFINE

Antiaging for oily and
blemish prone skin

Antibacterial
Facial
Cleanser

4 PHA

6.0 fl oz / 177 ml e

NEOSTRATA ANTIBACTERIAL FACIAL CLEANSER 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58414-8321
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM CHLORIDE 
COCAMIDOPROPYL BETAINE 
GLUCONOLACTONE 
GLYCINE 
LAURYL ALCOHOL 
METHYLPARABEN 
PANTHENOL 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CHLORIDE 
SODIUM LAURETH-3 SULFATE 
TROLAMINE 
SULFATE ION 
CHAMOMILE 
POLYQUATERNIUM-10 (400 MPA.S AT 2%) 
DISODIUM COCOAMPHODIACETATE 
Packaging
#Item CodePackage Description
1NDC:58414-8321-11 BOTTLE in 1 CARTON
1177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E04/25/2011
Labeler - NeoStrata Company Inc (605754829)
Establishment
NameAddressID/FEIOperations
Medicia Holdings, LLC091396697MANUFACTURE(58414-8321)

Revised: 08/2013
 
NeoStrata Company 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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