Label: ALLSAN ADVANCED HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 July 14, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 77% v/v

  • PURPOSE

    Antiseptic

  • USE[S]

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • WARNINGS

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

    Do not use

    •on children less than 2 months of age

    •on open skin wounds

    When using this product keep out of eyes, ears, mouth, or open orifices. Rinse eyes thoroughly with water and contact a physician if needed. Avoid ingestion.

    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.

  • 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 15-25C (59-77F)

    • Avoid freezing and excessive heat

  • INACTIVE INGREDIENTS

    Water (Aqua), Propylene Glycol, Glycerin, Isopropyl Myristate, Carbomer, Aminomethyl Propanol

  • SPL UNCLASSIFIED SECTION

    PERSONAL HYGIENE

    ANTI-SEPTIC HAND GEL

    MADE IN THE USA

    Distributed by CAG Beauty

    979 Corporate Boulevard,

    Linthicum Heights, MD 21090

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ALLSAN ADVANCED HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73904-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73904-002-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    2NDC:73904-002-0289 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/13/2020
    3NDC:73904-002-34100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    4NDC:73904-002-51151 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/13/2020
    5NDC:73904-002-84250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2020
    6NDC:73904-002-32946.4 mL in 1 CONTAINER; Type 0: Not a Combination Product04/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/13/2020
    Labeler - C-Care LLC (120585950)
    Establishment
    NameAddressID/FEIBusiness Operations
    C-Care LLC120585950manufacture(73904-002)