Label: HAND SANITIZER 01- hand sanitizer gel 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 January 20, 2021

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  • Active ingredient Purpose

    Ethyl Alcohol 62%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on the skin

  • WARNINGS

    Flammable, keep away from fire or flame.
    For external use only.

    Do not use near eyes.
    In case of contact, flush eyes with water.

    Stop use and ask a doctor
    If redness or irritation develop and persist for more than 72 hours.

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

  • DO NOT USE

    Do not use near eyes.
    In case of contact, flush eyes with water.

  • WHEN USING

    Do not use near eyes.
    In case of contact, flush eyes with water.

    Stop use and ask a doctor
    If redness or irritation develop and persist for more than 72 hours.

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

  • STOP USE

    Stop use and ask a doctor
    If redness or irritation develop and persist for 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.

  • DOSAGE & ADMINISTRATION

    Place a palmful (5 grams) of product in one hand.
    Spread on both hands and rub into skin until dry (1-2 min.).
    Place a smaller amount (2.5 grams) into one hand, spread overboth hands to wrist and rub into the skin until dry.
    Children must be supervised in the use of this product

  • STORAGE AND HANDLING

    /

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Carbomar, Fragrance, Glycerin, Propylene Glycol, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    74862-008-01 29ml

    74862-008-01 29ml

    74862-008-02 30ml

    74862-008-02 30ml

    74862-008-03 59ml

    74862-008-03 59ml

    74862-008-04 60ml

    74862-008-04 60ml

    74862-008-05 100ml

    74862-008-05 100ml

    74862-008-06 120ml

    74862-008-06 120ml

    74862-008-07 180ml

    74862-008-07 180ml

    74862-008-08 240ml

    74862-008-08 240ml

    74862-008-09 300ml

    74862-008-09 300ml

    74862-008-10 500ml

    74862-008-10 500ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  01
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74862-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74862-008-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    2NDC:74862-008-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    3NDC:74862-008-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    4NDC:74862-008-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    5NDC:74862-008-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    6NDC:74862-008-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    7NDC:74862-008-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    8NDC:74862-008-09300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    9NDC:74862-008-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    10NDC:74862-008-07180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/19/2020
    Labeler - Yiwu Shining Cosmetics Co.,Ltd (543002719)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yiwu Shining Cosmetics Co.,Ltd543002719manufacture(74862-008)
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