Label: PHARMACYS PRESCRIPTION INSTANT HAND SANITIZER-MOISTURIZERS AND VITAMIN E WITH SECURITY CLIP- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 10, 2020

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  • Active Ingredient

    Ethyl Alcohol 62% v/v.

  • Purpose

    Antiseptic

  • Use

    Help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    For external use only. Do not ingest or swallow.
    Flammable. Keep away from fire or flame.
    Do not apply around eyes. Do not use in ears & mouth.
    When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
    Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed on your palms and thoroughly spread on both hands. Rub into skin until dry.

    Other information

    • Store at room 20° C (68° to 77°F)
    • May discolor fabrics.
  • Inactive ingredients

    Water (Aqua), Glycerin, Propylene Glycol, Carbopol, Triethanolamine, Fragrance, Tocopheryl Acetate

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION INSTANT HAND SANITIZER-MOISTURIZERS AND VITAMIN E WITH SECURITY CLIP 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73398-111
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73398-111-012 in 1 PACKAGE08/14/2020
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/14/2020
    Labeler - SUHAN AEROSOLS (861140760)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUHAN AEROSOLS861140760manufacture(73398-111)
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