ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE- triclosan gel

Royal Antibacterial Tropical Fruit Hand Cleanse by

Drug Labeling and Warnings

Royal Antibacterial Tropical Fruit Hand Cleanse by is a Otc medication manufactured, distributed, or labeled by Filo America, Ningbo Pulisi Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

PURPOSE

Uses

for handwashing to decrease bacteria on the skin.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Wet hand, apply to hands, scrub thoroughly, Rinse.

WARNINGS

Warnings

For external use only.

Avoid getting into eyes. If this happens, rinse thoroughly with water.

DOSAGE & ADMINISTRATION

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

INACTIVE INGREDIENT

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYAL ANTIBACTERIAL TROPICAL FRUIT HAND CLEANSE 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50438-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50438-108-01	500 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/17/2013

Labeler - Filo America (943873703)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.		529047265	manufacture(50438-108)