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Name:Aromafields Lavender Scented Anti-bacterial Hand
Manufacturer:Alily (zhangzhou) Bath Products Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Fact

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.

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Drug Fact

Active Ingredient                        Purpose

Triclosan 0.15%                      Antiseptic

            Uses:

  • For hand moisturizing to decrease bacteria on the skin

Warnings:

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


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 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 Type HUMAN OTC DRUG Item Code (Source) NDC:49371-045
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.15 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER 82.1095 g  in 100 g
GLYCERIN 3 g  in 100 g
TROLAMINE 0.12 g  in 100 g
MINERAL OIL 5 g  in 100 g
CETOSTEARYL ALCOHOL 2.5 g  in 100 g
PETROLATUM 1.5 g  in 100 g
D&C RED NO. 33 0.0004 g  in 100 g
FD&C BLUE NO. 1 0.0001 g  in 100 g
ISOPROPYL PALMITATE 1.0 g  in 100 g
STEARIC ACID 1.0 g  in 100 g
CETEARETH-30 1.0 g  in 100 g
CETEARETH-12 1.0 g  in 100 g
GLYCERYL MONOSTEARATE 0.8 g  in 100 g
METHYLPARABEN 0.2 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A 0.12 g  in 100 g
PROPYLPARABEN 0.1 g  in 100 g
DIAZOLIDINYL UREA 0.1 g  in 100 g
EDETATE DISODIUM 0.1 g  in 100 g
LAVENDER 0.2 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49371-045-01 500 g in 1 BOTTLE None

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 Operations
ALILY (ZHANGZHOU) BATH PRODUCTS LTD. 531064269 manufacture

Revised: 06/2010 ALILY (ZHANGZHOU) BATH PRODUCTS LTD.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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