Label: HAND SANITIZING- alcohol gel

  • 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 March 14, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria on hands.

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product

    • 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 Poison Control Center immediately.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other information

    • Do not store above 105°F.
    • May discolor some fabrics.
    • Harmful to wood finishes and plastics.
    • You may report a serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903
  • Inactive ingredients

    Water, Fragrance, Glycerin, Triethanolamine, PEG-7 Glyceryl Cocoate, Hydrolyzed Jojoba Esters, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Urtica Dioica (Nettle) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1, Yellow 5.

  • PRINCIPAL DISPLAY PANEL - 232 mL Bottle Label

    time&again™

    HAND SANITIZING GEL

    Formulated with Glycerin,
    Aloe and Jojoba to Moisturize.

    Kills harmful bacteria and germs.

    GREEN APPLE

    232 mL 7.8 fl. OZ.

    PRINCIPAL DISPLAY PANEL - 232 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING   GREEN APPLE
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65365-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    SAGE (UNII: 065C5D077J)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65365-001-01232 mL in 1 BOTTLE, PUMP
    2NDC:65365-001-0259 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/01/2011
    Labeler - Sigan Industries (255106239)
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