Label: AROMAFIELDS LAVENDER SCENTED ANTI-BACTERIAL HAND - triclosan lotion

  • NDC Code(s): 49371-045-01
  • Packager: ALILY (ZHANGZHOU) BATH PRODUCTS LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated June 8, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Triclosan 0.15%                      Antiseptic

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  • INDICATIONS & USAGE

                Uses:

    • For hand moisturizing to decrease bacteria on the skin
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  • WARNINGS

    Warnings:

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


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  • 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
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  • 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 Blue No. 1

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  • PRINCIPAL DISPLAY PANEL

    piLabel picture

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  • INGREDIENTS AND APPEARANCE
    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
    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) 82.1095 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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49371-045-01 500 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
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