ANTIMICROBIAL FOAM- triclosan soap 
Afflink, 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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Antimicrobial Foam

Antimicrobial Foam

​Active Ingredient

​Triclosan 0.30%

Antimicrobial Foam

Uses

Antimicrobial Foam

Warnings

Antimicrobial Foam

Directions

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 Type HUMAN OTC DRUG Item Code (Source) NDC:54057-305
Route of Administration Topical DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3.0 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALOE VERA Leaf (UNII: ZY81Z83H0X)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54057-305-60 1000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/12/2012
Labeler - Afflink, Inc. (023121150)
Registrant - Betco Corporation, Ltd. (005050158)
Establishment
Name Address ID/FEI Business Operations
Betco Corpo, Ltd. 005050158 manufacture(54057-305) , label(54057-305) , pack(54057-305)

Revised: 12/2012
Document Id: b9b5b204-7f07-4428-81d8-1c64fdb4fa42
Set id: 14eaed47-f956-42a6-a6b4-d95e72122885
Version: 1
Effective Time: 20121204
 
Afflink, Inc.