ANTIBACTERIAL- triclosan liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Triclosan 0.3%

PURPOSE

antiseptic

INDICATIONS & USAGE

Antiseptic skin cleanser

WARNINGS

For external use only.

Avoid contact with the eyes.

DOSAGE & ADMINISTRATION

Add small amount of soap to wet hands and forearms.

Develop lather.

Scrub well and rinse thoroughly after washing.

QUESTIONS

Questions or Comments?

1 800 760-3236 (Monday to Friday 8:30AM - 5:00PM EST)

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

INACTIVE INGREDIENT

Acrylates/Steareth-20 Methacrylate Copolymer

Citric Acid

DMDM Hydantoin

Fragrance

Lauramide DEA

PEG75 Lanolin

Polyquaterium 7

Propylene Glycol

Sodium C25-15 Pareth-15 Sulfonate

Sodium Hydroxide

Sodium Lauryl Sulfate

Styrene/PVP Copolymer

Tetrasodium EDTA

Water

PRINCIPAL DISPLAY PANEL

Antibacterial Lotion Soap, 1 gal.

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1865
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURAMIDE (UNII: 3BD22052MO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE SODIUM (UNII: MP1J8420LU)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1865-2	60 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
2	NDC: 52380-1865-4	120 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
3	NDC: 52380-1865-6	480 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
4	NDC: 52380-1865-3	360 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
5	NDC: 52380-1865-9	3785 g in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/1998	07/01/2020

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-1865)