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 May 12, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Uses

    As an external disinfectant. Suitable for application on hand. Rub the gel upon application. Recommended for repeated use. Suitable fo use above ago 2 year.

  • Warnings

    For external use only.

    Flammable - Keep away from heat or flame.

    When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    Stop using and ask doctor if irritation or redness develop and last more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Apply a small amount in your palm and rub hands together briskly until dry.

    Children under 6 should be supervised when using this product.

    Other information

    Do not store above 105°F (40°C).

    May discolor certain wood surfaces.

    Questions ?
    Call +1 954-773-0003

  • Inactive ingredients

    Purified water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, Aloe Barbadensis leaf juice.

  • Product Label

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77106-002
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77106-002-01200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2020
    Labeler - Resource Recovery & Trading LLC (012636159)
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