ROYAL ANTIBACTERIAL MANGO MOISTURIZING HAND- triclosan gel
Filo America

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.

----------

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 Red No. 33

ROYAL

ANTIBACTERIAL

Soap

mango

Moisturizing

Hand Soap

15 FL OZ (444ml)

Front

Back

ROYAL ANTIBACTERIAL MANGO MOISTURIZING HAND
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50438-004
Route of Administration	TOPICAL

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)
SUDAN RED (UNII: 8C1M5O3ECT)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50438-004-00	444 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015	12/25/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/01/2015	12/25/2017

Labeler - Filo America (943873703)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(50438-004)

Revised: 12/2017

Document Id: 612a249a-6c65-4d78-e053-2a91aa0a4eec

Set id: f52ce735-580e-4e82-a514-6e4c22f0477e

Version: 3

Effective Time: 20171225

Filo America