Label: 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 October 23, 2020

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  • Active Ingredient(s)

    Ethanol 70%. Purpose: Antimicrobial

    Active ingredient

  • Purpose

    Hand sanitizer to help decrease bacteria on the skin.

    Purpose

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    Warning

  • Do not use

    Do not use in or near the eyes. If contact occurs, flush thoroughly with water. Do not use

  • STOP USE

    Stop use and contact doctor if redness and irritation develops and persists.

    Stop use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

    Keep out of children

  • Directions

    Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

    Dosage & Admin

  • Other information

    Store below 110°F (43°C)

    Other info

  • Inactive ingredients

    Aqua (Water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Animomethyl Propanol, Aloe Barbadensis Leaf Extract.

    Inactive ingredient

  • INDICATIONS & USAGE

    Put enough product on hands to cover all surfaces. Rub hands together until hands feel dry. This should take around 20 seconds. Note: Do not rinse or wipe off the hand sanitizer before it is dry; it may not work as well against germs.

    Indicate

  • Package Label - Principal Display Panel

    Instant Hand Sanitizer. 50mL

    Package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80380-071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.6 mL  in 100 mL
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.15 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80380-071-0170 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/23/2020
    Labeler - Shedrain Corporation (009025552)
    Establishment
    NameAddressID/FEIBusiness Operations
    XIAMEN ROSEMARY BIOTECHNOLOGY  CO.,LTD543263460manufacture(80380-071)
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