Label: FREEMAN PACKAGING HAND SANITIZER- alcohol liquid

  • NDC Code(s): 71734-201-01
  • Packager: JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., 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 October 9, 2017

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  • Active Ingredient

    Ethyl Alcohol  62%

    Purpose

    antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only- hands.

    Flammable. Keep away from heat and 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.

    When using this product

    • keep out of eyes. In case of contact with eyes, immediately flush with water and call a doctor.
    • avoid contact with broken skin.

    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.

  • 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
  • Other Information

    • do not store above 105 F.
    • may discolor some babrics
    • harmful to wood finishes and plastics
  • Inactive Ingredients

    alcohol, aloe vere gel, extracts of juniper, eucalyptus oil, carbomer, thymol essence (radix), diisoprpanol amine, purified water.

  • Product Labeling

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    FREEMAN PACKAGING HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-201
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-201-017.5 mL in 1 BOTTLE; Type 0: Not a Combination Product10/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/09/2017
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534manufacture(71734-201)
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