ANTIMICROBIAL FOAM- tricolsan soap

Antimicrobial Foam by

Drug Labeling and Warnings

Antimicrobial Foam by is a Otc medication manufactured, distributed, or labeled by Afflink, Inc., Betco Corporation, Ltd., Betco Corpo, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL FOAM 
tricolsan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54057-305
Route of Administration	Topical

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)