Label: SYMMETRY HAND SANITIZER- hand sanitizer 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 December 11, 2020

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient(s)

    Ethyl alcohol 62% Purpose - Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For hand washing to decrease bacteria on the skin that could casue disease

  • Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Do not use

    in or near the eyes

    Stop use and ask a doctor if

    irritation and redness develop
    condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Do not use

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • WHEN USING

    For external use only. Do not use in the eyes.

  • Package Label - Principal Display Panel

    label

  • Directions

    • dispense entire contents of packet into hands. Rub hands together until dry.
  • Other information

    Flammable, keep away from fire or flame.

  • Inactive ingredients

    water (aqua), acrylate crosspolymer, glycerine, porpylene glycol, isopropyl myristate, fragrance (parfum), aminomethyl propanol, alor barnadensis juice, and tocopheryl acetate

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • label

    label

  • INGREDIENTS AND APPEARANCE
    SYMMETRY HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68320-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 0.9 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE (UNII: AUG1H506LY)  
    GLYCERIN 1,3-DIMETHYL ETHER (UNII: A0JF0DT9XK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68320-800-021 in 1 BOX12/30/2020
    1NDC:68320-800-010.9 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/30/2020
    Labeler - Orlandi Inc. (079801467)
    Registrant - orlandi Inc (079801467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Buckeye International Inc.077132280manufacture(68320-800)
    Establishment
    NameAddressID/FEIBusiness Operations
    Orlandi Inc079801467repack(68320-800) , relabel(68320-800)
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