Label: BENJAMINS HAND SANITIZER- hand sanitizer 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 December 31, 2021

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

  • Purpose

    Purpose: Antiseptic/ Antibacterial Agent

  • Use

    As a Hand Sanitizer to help reduce bacteria on skin.

  • Warnings

    For external use only. Flammable.

    Keep away from heat or flame.

    Do not apply around eyes. In case of contact flush eyes with water.

    KEEP OUT OF REACH OF CHILDREN.

  • Do not use

    • Do not apply around eyes. In case of contact flush eyes with water.
  • WHEN USING

    Do not apply around eyes. In case of contact flush eyes with water.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN.

    Children under 6 years of age should be supervised by an adult.

  • Directions

    Place enough product in the palms to thoroughly cover hands. Rub hands together briskly until dry. Do not rinse. Children under 6 years of age should be supervised by an adult.

  • Other information

    • Store in a Cool Place below 30 OC.
  • Inactive ingredients

    Water, triethanolamine, carbomer, isopropyl myristate, glycerine, fragrance, Aloe Vera, Colour (Blue no.1)

  • Package Label - Principal Display Panel for Benjamins Hand Sanitizer 60 mL

    Benjamins Hand Sanitizer 60 mL NDC: 82338-438-60 Benjamins Hand Sanitizer 60 mL

  • Package Label - Principal Display Panel for Benjamins Hand Sanitizer 240 mL

    Benjamins Hand Sanitizer 240 mLBenjamins 240 mL Hand Sanitizer. NDC : 82338-438-24

  • Package Label - Principal Display Panel for Benjamins Hand Sanitizer 3.8 Lt

    Benjamins Hand Sanitizer 3.8 Lt. NDC: 82338-438-3.8 Benjamins Hand Sanitizer 3.8 Lt

  • INGREDIENTS AND APPEARANCE
    BENJAMINS HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82338-438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL459.96 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.98 mL  in 1000 mL
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 3.05 mL  in 1000 mL
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 3.6 g  in 1000 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0002 g  in 1000 mL
    TROLAMINE (UNII: 9O3K93S3TK) 4.82 mL  in 1000 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.116 g  in 1000 mL
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    ISOCYCLEMONE E (UNII: 1GD7ODM28Y)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    Product Characteristics
    Colorblue (Light Blue) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82338-438-6060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2021
    2NDC:82338-438-24240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/31/2021
    3NDC:82338-438-383800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/31/2021
    Labeler - P. A BENJAMIN MANUFACTURING CO LTD (873219000)
    Establishment
    NameAddressID/FEIBusiness Operations
    P. A BENJAMIN MANUFACTURING CO LTD873219000manufacture(82338-438)
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