Label: 1SOURCE ADVANCED 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 May 15, 2020

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria on the skin that could cause disease

    Recommended for repeated use

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame

  • WHEN USING

    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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

    Place enough products in your palm to thoroughly cover your hands

    Rub hands together briskly until dry

    No rinsing required

    No towels needed

  • Other information

    Do not store above 110F (43C)

    May discolor certain fabrics or surfaces

  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Glycerol, Vitamin E,  Aloe Extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    1SOURCE ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77871-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    ALOE (UNII: V5VD430YW9)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77871-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:77871-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:77871-001-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    4NDC:77871-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    5NDC:77871-001-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    6NDC:77871-001-062000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    7NDC:77871-001-073785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    Labeler - AVS Energy Inc (080219162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch414137820manufacture(77871-001)
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