Label: PACIFIC GARDEN FOAM HAND SANITIZER, FRAGRANCE FREE, DYE FREE- alcohol soap

  • 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 January 25, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% (v/v)

  • Purpose

    Antimicrobial

  • Uses

    • To decrease bacteria on skin that could cause disease.
    • Recommended for repeated use.
  • Warnings

    • FLAMMABLE, keep away from fire or flame
    • For external use only

    When using this product do not use in or near eyes.

    Stop use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, seek immediate medical attention or call a poison control center.

  • Directions

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

    • Water/Aqua, DEA-C8-18 Perfluoroalkylethyl Phosphate, Glycerin, Isopropyl Myristate
  • SPL UNCLASSIFIED SECTION

    Warning: This product contains a chemical known to the state of California to cause cancer.

  • PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

    pacific
    garden

    Foam Hand Sanitizer
    Fragrance Free, Dye Free

    4-1000 mL(33.8 FL OZ)

    PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PACIFIC GARDEN FOAM HAND SANITIZER, FRAGRANCE FREE, DYE FREE 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54622-689
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54622-689-301000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2000
    2NDC:54622-689-51800 mL in 1 BAG; Type 0: Not a Combination Product01/01/2000
    3NDC:54622-689-47950 mL in 1 BAG; Type 0: Not a Combination Product01/01/2000
    4NDC:54622-689-1245 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2000
    Labeler - Georgia-Pacific Consumer Products LP (806142217)
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