Label: DOTS APPLE CINNAMON ANTI-BACTERIAL 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 May 3, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Ethyl Alcohol 62%                      Antiseptic

  • INDICATIONS & USAGE

                Uses:

    • To decrease bacteria on the skin that could cause diseases
    • Recommended for repeated use.
  • WARNINGS

    Warnings:

    For external use only-hands.

    Flammable-keep away from heat and flame

    When using this products

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.
    Stop use and ask a doctor if skin irritation develops.
    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and allow to dry without wiping
    • For children under 6, use only under adult supervision
    • Not recommended for infants
  • STORAGE AND HANDLING

        Other Information

    • Do not store above 105 F
    • May discolor some fabrics
    • Harmful to wood finishes and plastics

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water (aqua), Glycerin, Triethanolamine, Fragrance (Parfume), PEG-40 Hydrogenated Castor Oil, Carbomer, DMDM Hydantoin, Hydrogenated Jojoba Oil, FD and C Red No. 40, D and C Red No. 33

  • PRINCIPAL DISPLAY PANEL

    pictuLabel picture

  • INGREDIENTS AND APPEARANCE
    DOTS APPLE CINNAMON ANTI-BACTERIAL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49371-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 33.9486 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.3 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.3 g  in 100 g
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.8 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.2 g  in 100 g
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.006 g  in 100 g
    D&C RED NO. 33 (UNII: 9DBA0SBB0L) 0.0004 g  in 100 g
    APPLE (UNII: B423VGH5S9) 0.2 g  in 100 g
    CINNAMON (UNII: 5S29HWU6QB) 0.2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49371-034-0145 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33305/20/2010
    Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)
    Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALILY (ZHANGZHOU) BATH PRODUCTS LTD.531064269manufacture
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