Label: 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 November 13, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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 heat or flame

  • Do not use

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

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

    • Avoid contact with broken skin
    • Do not inhale or ingest.
  • STOP USE

    Stop use and ask a doctor if irritation or rash oppears 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 product in your palm to thoroughly cover your hands
    • Rub hands together briskly until dry
    • Children under 6 years of ages should be supervised when using this product.
  • Other information

    • Do not store above 110℉（40℃）
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water, Carbomer, AMP-95 aminomethly propanol, jasmine scent, aloe vera, FD&C yellow no.5(tartrazine), and FD&C blue no.1

  • Package Label - Principal Display Panel

    3780ml3780ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75586-010
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75586-010-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/04/2020
    Labeler - Dongyang Mukang Pharmaceutical Factory (554531139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongyang Mukang Pharmaceutical Factory 554531139manufacture(75586-010)
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