Label: ADVANCED HAND SANITIZER liquid

  • 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 April 30, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warning

    Flammable. Keep away from heat or flame

    For external use only.

  • Do not use near eyes

    In case of contact rinse eyes thoroughly with water.

  • Stop use

    Stop use and see a doctor if imtation 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

    Put enough sanitizer in your palm to cover both hands,Rub hands together brishly until dry,Children under six should be supervised

  • Other

    • Store below 110F(43C)
    • May discolor some fabrics or surfaces
  • Inactive ingredients

    Alcohol Denat,Water(aqua),Glycerin,Carbomer,Aminomethylpropanol,Aloe Barbadensis Leaf Juice,Tocopherol

  • WHEN USING

  • Package Label - Principal Display Panel

    4132

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    advanced hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75541-005
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75541-005-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    2NDC:75541-005-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    3NDC:75541-005-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    4NDC:75541-005-0450 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    5NDC:75541-005-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    6NDC:75541-005-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    7NDC:75541-005-07250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    8NDC:75541-005-08480 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    9NDC:75541-005-093780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    10NDC:75541-005-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2020
    Labeler - Ningbo Meiteli Cosmetic Co., Ltd. (546624772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Meiteli Cosmetic Co., Ltd.546624772manufacture(75541-005)
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