ANTIBACTERIAL- triclosan liquid 
Aplicare Products, LLC.

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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1865 Antibacterial

Triclosan 0.3%

antiseptic

Antiseptic skin cleanser

For external use only.

Avoid contact with the eyes.

Add small amount of soap to wet hands and forearms.

Develop lather.

Scrub well and rinse thoroughly after washing.

Questions or Comments?

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

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

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

Antibacterial Lotion Soap, 1 gal.

Gallon Bottle

ANTIBACTERIAL 
triclosan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1865
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1865-260 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201807/01/2020
2NDC:52380-1865-4120 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201807/01/2020
3NDC:52380-1865-6480 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201807/01/2020
4NDC:52380-1865-3360 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201807/01/2020
5NDC:52380-1865-93785 g in 1 BOTTLE; Type 0: Not a Combination Product02/20/201807/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/199807/01/2020
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-1865)

Revised: 1/2020
Document Id: 9d4d66f7-fa47-e832-e053-2a95a90a8b62
Set id: b24b2229-cf04-4a01-8c9f-7d823f501d75
Version: 3
Effective Time: 20200129
 
Aplicare Products, LLC.