Label: ADVANCE HAND SANITIZER gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     75239-005-01, 75239-005-02, 75239-005-03, 75239-005-04, view more
    75239-005-05, 75239-005-06, 75239-005-07, 75239-005-08, 75239-005-09, 75239-005-10, 75239-005-11, 75239-005-12, 75239-005-13, 75239-005-14, 75239-005-15, 75239-005-16, 75239-005-17
  • Packager: Guangzhou Youxing Cosmetics CO.,LTD
  • 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 August 12, 2020

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  • Active Ingredient(s)

    Ethyl alcohol 75% V/V

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    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 irritation or rash occurs. These may be signs of a serious condition.

  • 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 product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water(Aqua). Aloe Barbadensis Leaf Juice,Carbomer, Fragrance. Glycerin,Propylene Glycol ,Tocopheryl Acetate(Vitamin E).Triethanolamine, FD&C Blue No 1. FD&C Yellow No 5

  • Advance HAnd Sanitizer Refreshing Gel Ethyl Alcohol Antiseptic 75% (240 ml/8 oz)

    Advance Hand Sanitizer 240 ml/8 oz

  • INGREDIENTS AND APPEARANCE
    ADVANCE HAND SANITIZER 
    advance hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75239-005
    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
    GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 g  in 100 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.05 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.5 g  in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.05 g  in 100 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.05 g  in 100 mL
    CARBOMER 934 (UNII: Z135WT9208) 1 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.3 g  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.05 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75239-005-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    2NDC:75239-005-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    3NDC:75239-005-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    4NDC:75239-005-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    5NDC:75239-005-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    6NDC:75239-005-06150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    7NDC:75239-005-07180 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    8NDC:75239-005-08200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    9NDC:75239-005-09240 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    10NDC:75239-005-10250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    11NDC:75239-005-11300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    12NDC:75239-005-12350 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    13NDC:75239-005-13500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    14NDC:75239-005-14650 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    15NDC:75239-005-151000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    16NDC:75239-005-163800 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    17NDC:75239-005-175000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/21/2020
    Labeler - Guangzhou Youxing Cosmetics CO.,LTD (544355953)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Youxing Cosmetics CO.,LTD544355953manufacture(75239-005)
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