Label: FRIUTS AND FLOWERS CLEAN COTTON WATERLESS HAND SANITIZER- alcohol liquid

  • 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 August 5, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                              

    Ethyl Alcohol 62%

                                             

  • PURPOSE

    Purpose:

    Antiseptic
  • INDICATIONS & USAGE

    Uses  

    To decrease bacteria on hands that can cause disease

    Recommended for repeated use.
  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from heat and flame

    Other Information:

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics


  • DOSAGE & ADMINISTRATION

    Directions   

    Wet hands thoroughly with products and allow to dry without wiping.
  • KEEP OUT OF REACH OF CHILDREN

    For children under 6, use only under adult supervision

    Not recommended for infants.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Propylene Glycol,  PEG-40 Hydrogenated Castor Oil, Fragrance, Carbomer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Ester, Tocopheryl Acetate, Ascorbyl Palmitate, Disodium EDTA, D and C red No. 33, FD and C Blue No. 1
  • PRINCIPAL DISPLAY PANEL

    labe
    label
  • INGREDIENTS AND APPEARANCE
    FRIUTS AND FLOWERS CLEAN COTTON WATERLESS HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49981-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.00 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 34.0498 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.8 g  in 100 g
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 1.0 g  in 100 g
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 0.29 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.28 g  in 100 g
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) 0.01 g  in 100 g
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 0.01 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.03 g  in 100 g
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0000875 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0001125 g  in 100 g
    HYPROMELLOSE 2208 (15000 CPS) (UNII: Z78RG6M2N2) 0.01 g  in 100 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g  in 100 g
    ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.01 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49981-022-0190 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/10/2010
    Labeler - Xiamen Anna Global Co., Ltd (527060704)
    Registrant - Xiamen Anna Global Co., Ltd (527060704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Anna Global Co., Ltd527060704manufacture