Your browser does not support JavaScript! ANTIMICROBIAL FOAM (TRICOLSAN) SOAP [AFFLINK, INC.]
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ANTIMICROBIAL FOAM (tricolsan) soap
[Afflink, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Antimicrobial Foam

​Active Ingredient

​Triclosan 0.30%

Antimicrobial Foam

Uses

  • ​Antibacterial hand cleaner.
  • Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

Antimicrobial Foam

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • Children under the age of 6 should be supervised by an adult when using this product.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.

Antimicrobial Foam

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 0.8 mL of product onto wet palm.
  • Rub hands together to distribute product, then rinse hands with clean.

Antimicrobial Foam

Inactive Ingredients

​Water, Potasium cocoate (contains coconut), Propylene Glycol, Glycerine, DMDM Hydantoin, Fragrance, FD&C Yellow #5, Aloe Barbadensis Leaf Juice. FD&C Red #40.

Antimicrobial Foam

Purpose

​Antibacterial

Antimicrobial Foam

KEEP OUT OF REACH OF CHILDREN

Antimicrobial Foam

AFFEX CLEANING SOLUTIONS

Antimicrobial Foam Soap

Foaming Skin Cleanser with Triclosan

MEDICAL EMERGENCY:

(800)424-9300

NET CONTENTS: 1000 mL

ITEM #305-60

Afflink 305.jpg

ANTIMICROBIAL FOAM 
tricolsan soap
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54057-305
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN3.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POTASSIUM COCOATE 
PROPYLENE GLYCOL 
GLYCERIN 
EDETATE SODIUM 
DMDM HYDANTOIN 
FD&C YELLOW NO. 5 
ALOE VERA Leaf 
FD&C RED NO. 40 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54057-305-601000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/12/2012
Labeler - Afflink, Inc. (023121150)
Registrant - Betco Corporation, Ltd. (005050158)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corpo, Ltd.005050158manufacture(54057-305), label(54057-305), pack(54057-305)

Revised: 12/2012
 
Afflink, Inc.

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