AROMAFIELDS PLUMERIA SCENTED ANTI-BACTERIAL HAND- triclosan lotion

Aromafields Plumeria Scented Anti-Bacterial Hand by

Drug Labeling and Warnings

Aromafields Plumeria Scented Anti-Bacterial Hand by is a Otc medication manufactured, distributed, or labeled by ALILY (ZHANGZHOU) BATH PRODUCTS LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                        Purpose

Triclosan 0.15%                      Antiseptic

INDICATIONS & USAGE

            Uses:

• For hand moisturizing to decrease bacteria on the skin

WARNINGS

Warnings:

For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions

• Apply a small amount to hands
  
• Massage until absorbed into skin
• Apply daily as necessary
  
• For children under 6, use only under adult supervision

INACTIVE INGREDIENT

Inactive Ingredients

Water (aqua), Mineral Oil, Glycerin, Cetearyl Alcohol, Petrolatum, Isopropyl Palmitate, Stearic Acid, Ceteareth-25, Cetearith-6, Glyceryl Stearate SE,  Fragrance, Methylparaben, Carbomer, Triethanolamine, Propylparaben, Diazolidinyl  Urea, Disodium EDTA, D and C Red No. 33, FD and C Red No. 40

PRINCIPAL DISPLAY PANEL

pi

INGREDIENTS AND APPEARANCE

AROMAFIELDS PLUMERIA SCENTED ANTI-BACTERIAL HAND  
triclosan lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49371-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	82.1090 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	3 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.12 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP)	5 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	2.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U)	1.5 g  in 100 g
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0005 g  in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.0005 g  in 100 g
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)	1.0 g  in 100 g
STEARIC ACID (UNII: 4ELV7Z65AP)	1.0 g  in 100 g
CETEARETH-30 (UNII: 1R9DCZ5FOX)	1.0 g  in 100 g
CETEARETH-12 (UNII: 7V4MR24V5P)	1.0 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.8 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.2 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.12 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.1 g  in 100 g
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.1 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.1 g  in 100 g
PLUMERIA EXTRACT (UNII: LGC8P2PC4H)	0.2 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49371-046-01	500 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	06/20/2010

Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)

Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)

Establishment
Name	Address	ID/FEI	Business Operations
ALILY (ZHANGZHOU) BATH PRODUCTS LTD.		531064269	manufacture