AROMAFIELDS LAVENDER SCENTED ANTI-BACTERIAL HAND  - triclosan lotion 
ALILY (ZHANGZHOU) BATH PRODUCTS LTD.

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.

----------

Drug Fact

Active Ingredient                        Purpose

Triclosan 0.15%                      Antiseptic

            Uses:

Warnings:

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


Directions

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 Blue No. 1

piLabel picture

AROMAFIELDS LAVENDER SCENTED ANTI-BACTERIAL HAND  
triclosan lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49371-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 82.1095 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) 0.0004 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001 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
LAVENDER (UNII: 9YT4B71U8P) 0.2 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49371-045-01500 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33306/20/2010
Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)
Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)
Establishment
NameAddressID/FEIBusiness Operations
ALILY (ZHANGZHOU) BATH PRODUCTS LTD.531064269manufacture

Revised: 6/2010
Document Id: 35006f88-a5bc-4633-ab70-9cafa6f41301
Set id: abc68e42-b5ca-4f2b-a9c4-e77f0b5459b3
Version: 1
Effective Time: 20100608
 
ALILY (ZHANGZHOU) BATH PRODUCTS LTD.