Label: FLOD HAND SANITIZER GEL, ALOHA-GREEN APPLE SCENT- 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 March 9, 2022

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  • DRUG FACTS

  • Active Ingredient:

    Ethyl Alcohol 70% v/v

    Purpose

    Antimicrobial Use

  • Use:

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings:

    Flammable, keep away from fire or flame. Exclusively for external use.  Do not ingest, in case of accidental ingestion consult your doctor immediately. Keep away from the eyes, in case of accidental contact with eyes, rinse with water and consult your doctor. In case of irritation or redness, discontinue use, if discomfort persists consult your doctor.

    Keep out of reach of children,

    supervision is required for children under 6 years of age.

  • Directions:

    Empty the contents of the packet into the palm of the hand, rub both hands until the product covers the entire surface of the hands, let it
    absorb. No need to rinse, wash or dry hands.

  • Inactive ingredients:

    Water, carbomer, triethanolamine, glycerin, Castor Oil, tocopheryl acetate, Aloe vera extract. Fragrance.

  • Other information:

    Store below 110ºF (43ºC)

  • Questions or comments:

    a.comercial@alumpack.com

  • Package Labeling:

    LabelLabel2Label3Label4Label5

  • INGREDIENTS AND APPEARANCE
    FLOD HAND SANITIZER GEL, ALOHA-GREEN APPLE SCENT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81998-001(NDC:77739-001)
    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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81998-001-0112 in 1 BOX03/23/2020
    1100 in 1 PACKET
    11.7 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/23/2020
    Labeler - Aluma Packaging Corporation, S.A. de C.V. (951614095)