Label: HAND SANITIZER- 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 June 23, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL DENAT. 70% V/V

  • PURPOSE

    ANTISEPTIC

  • USES

    HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

  • WARNINGS

    Flammable. Keep away from fire or flame. For external use only. Do not ingest, if swallowed seek medical help. Avoid contact with eyes.

  • Keep out of reach of children.

    Children under 6 years old to use under adult supervision. in case of irritation, discontinue use and consult your doctor.

  • DIRECTIONS

    Apply the gel on the hands and rub gently for 20 seconds until the product evaporates. allow to dry without wiping. Not recommended for infants.

  • OTHER INFORMATION

    Store below 106°F (41°C). May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENTS

    Alcohol denat., Water/Aqua, Acrylates/C10-30 Alkyl Crosspolymer, Aminomethyl propanol, Fragrance/Parfum, Glycerin, Citral*, Linalool*, Butylene glycol, Alor barbadensis leaf extract.  *Naturally found in essential oils

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Medex Hand Sanitizer_50mL

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76854-102
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76854-102-1150 mL in 1 TUBE; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - Fujian Shuangfei Daily Chemicals Co.,Ltd. (527296914)
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