Royal Antibacterial (Mango) (Triclosan) Gel [Filo America] -

ROYAL ANTIBACTERIAL (MANGO) (TRICLOSAN) GEL [FILO AMERICA]
PDF | XML

View All Sections

Active Ingredient

Triclosan 0.15%
Purpose

Antibacterial
Uses

for handwashing to decrease bacteria on the skin.
Warnings

For external use only.
When using this product

Avoid contact with eyes. In case of eye contact, flush with water.
Stop use and ask a doctor

If irritation and redness develops.
Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- pump into hands
- lather vigorously for at least 15 seconds
- rinse and dry thoroughly.
Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Chloride, Fragrance, Citric Acid, Peg-150 Distearate, Tetrasodium Edta, FD&C Yellow No.5, FD&C Blue No.1
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYAL ANTIBACTERIAL (MANGO)
triclosan gel

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50438-601-01	221 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/05/2015

Labeler - Filo America (943873703)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(50438-601)

View All Sections

Medic