Label: INSTANT HAND SANITIZER- 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 16, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl

    Alcohol 66.5%

  • Purpose

    Antiseptic

  • Use

    For handwashing to decrease bacteria on skin without soap and water.

  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Keep out of reach of children.

    Do not use in eyes, if this happens, rinse thoroughly with water.

    Stop use, ask a doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands & wrists thoroughly with product and allow to dry without wiping
  • Inactive ingredients

    aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - 0.9g Packet Label

    Provision Medical PRODUCTS

    INSTANT

    HAND

    SANITIZER

    0.9 g (1/32 oz.)

    Manufactured for

    Provision Medical Products

    Palm Desert, CA 92211

    Principal Display Panel - 0.9g Packet Label
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3554
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe (UNII: V5VD430YW9)  
    carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    d&c green no. 5 (UNII: 8J6RDU8L9X)  
    d&c yellow no. 10 (UNII: 35SW5USQ3G)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-3554-10.9 g in 1 PACKET; Type 0: Not a Combination Product03/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/16/2015
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-3554)
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