PROBLEND ANTIBACTERIAL FOAM- triclosan liquid

PROBLEND Antibacterial Foam by

Drug Labeling and Warnings

PROBLEND Antibacterial Foam by is a Otc medication manufactured, distributed, or labeled by Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT

Active Ingredient

Triclosan  0.3 %

PURPOSE

Purpose

Antiseptic

DOSAGE & ADMINISTRATION

Uses

• For hand washing to decrease bacteria on the skin.

WARNINGS

Warnings

For external use only

When using this product

• Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

• Pump into hands, wet as needed.
• Lather vigorously for at least 15 seconds.
• Wash skin, rinse thoroughly and dry.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerine, Aloe Vera, Sodium Chloride, Sodium Xylenesulfonate, DMDM hydantion, FD&C Yello # 5. FD&C Red # 40

SPL UNCLASSIFIED SECTION

Manufactured by:

Morgan-Gallacher, Inc.

8707 Millergrove Drive

Santa Fe Springs, CA 90670

(562) 695-1232

INGREDIENTS AND APPEARANCE

PROBLEND ANTIBACTERIAL FOAM 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50241-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.30 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50241-142-01	3.79 kg in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2014

Labeler - Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. (028311595)

Registrant - Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. (028311595)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc.		028311595	manufacture(50241-142)