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Antibacterial 2X by Sante Manufacturing Inc

Dosage form: liquid
Ingredients: TRICLOSAN 1.15mg in 1mL
Labeler: Sante Manufacturing Inc
NDC Code: 71020-009

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.

Active Ingredient - Triclosan 0.115%

Purpose - Antibacterial

Uses - for handwashing to decrease bacteria on the skin

Warning For external use only

Stop use and ask a doctor if irritation or redness develops

When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse

Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow # 5, Red# 33

ANTIBACTERIAL  2X
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN1.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
SODIUM CHLORIDE 
DMDM HYDANTOIN 
EDETIC ACID 
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:71020-009-641900 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/19/2016
Labeler - Sante Manufacturing Inc (242048747)
Establishment
NameAddressID/FEIOperations
Sante Manufacturing Inc242048747manufacture(71020-009)

Revised: 10/2016
 
Sante Manufacturing Inc

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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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