Label: 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 April 13, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Alcohol 72% 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, glycerin, Arcylates/vinyl, isodecanote cross polymer, amino ethyl propanol, Panthenol, Aloe Barbados leaf juice, Tocopheryl Acetate

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75144-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISODECYL ALCOHOL (UNII: 3160X491M7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75144-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:75144-001-0269 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:75144-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:75144-001-04125 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:75144-001-05240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    6NDC:75144-001-06308 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    7NDC:75144-001-07502 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    8NDC:75144-001-081000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Bellapierre Cosmetics Inc (802861802)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZheJiang Ushas Cosmetics Co., Ltd544910474manufacture(75144-001)