Label: ALTRA HAND SANITIZER WITH ALOE AND VITAMIN E- alcohol solution

  • NDC Code(s): 30805-014-06, 30805-014-09, 30805-014-12
  • Packager: Buckeye International, Inc.
  • 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 5, 2020

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  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antibacterial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that could cause disease
    • Recommended for repeated use
  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    When using this product do not use in or near eyes.

    If in eyes, flush thoroughly with water.

    If irritation or rash appears and persists, stop use and see a physician.

    Keep out of reach of children. If swallowed, call a physician or Poison Control Center immediately.

  • Directions

    • Dispense an adequate amount of hand sanitizer
    • Rub hands togetheruntil completely dry
  • Other information

    • Do not store above 110 F (43 C)
    • May discolor some fabrics or surfaces
  • Inactive ingredients

    Water (Aqua), Acrylate Crosspolymer, Glycerine, Propylene Glycol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, and Tocopheryl Acetate.

  • Questions?

    Call Buckeye International, Inc. 314-291-1900

    Monday through Friday 8:00 a.m. to 5:00 p.m. CST

  • PRINCIPAL DISPLAY PANEL

    Low Profile

    Altra

    Hand Sanitizer

    with Aloe and Vitamin E

    Manufactured by:

    Buckeye International

    2700 Wagner Place Maryland Heights

    MO 63043 USA (314) 291-1900

    Product # 71063000

    Net Contents 1000 mL (33.8 fl oz)

    container label

  • INGREDIENTS AND APPEARANCE
    ALTRA HAND SANITIZER WITH ALOE AND VITAMIN E 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30805-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30805-014-0659.2 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2020
    2NDC:30805-014-12473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2020
    3NDC:30805-014-091000 mL in 1 BAG; Type 0: Not a Combination Product04/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/05/2020
    Labeler - Buckeye International, Inc. (077132280)
    Establishment
    NameAddressID/FEIBusiness Operations
    Buckeye International, Inc.077132280manufacture(30805-014)
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