Label: HAND SANITIZER WIPES- alcohol solution

  • 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 5, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.1% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial

  • Use

    Kill germs and remove dirt

  • Warnings

    For external use only.

  • Do not use

    if you are allergic to any of ingredients

  • WHEN USING

    When using this product do not get into eyes. If contact occurs, wash thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops and continuous for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Adults and children 3 years and over

    Children under 3 years ask a doctor before use

    Wipe with wipes and let dry

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Cool Wipes Baby with Plantain Extract - Inactive Ingredients

    Water, Glycerin, Propylene glycol, Plantago Major Leaf, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Ethylparaben, Cetrimonium Bromide, Citric Acid, Parfum

  • Cool Wipes Safe Clean enriched with vitamins - Inactive ingredients

    Water, Glycerin, Propylene glycol, Tocopheryl acetate, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Panthenol, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Citric Acid, Parfum, Limonene, Citral

  • Cool Wipes Safe Clean enriched with plantain extract

    Water, Glycerin, Propylene glycol, Plantago Major Leaf, Peg-40 Hydrogenated Castor Oil, Cocamidopropyl Betaine, PPG-2 Methyl Ether, Ethylparaben, 2-Bromo-2-Nitropropane- 1,3-Diol, Ethylparaben, Cetrimonium Bromide, Citric Acid, Parfum

  • Cool Wipes Safe Clean enriched with plantain extract - Package Label

    15 Wipes NDC:77848-001-15

    15 wipes

  • Cool Wipes Safe Clean enriched with vitamins - Package Label

    15 Wipes NDC: 77848-002-15

    15 wipes

  • Cool Wipes Baby with Plantain Extract - Package Label

    15 wipes NDC: 77848-003-15

    15 wipes

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WIPES 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77848-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    2-NITROPROPANE (UNII: GKV234L2QH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77848-003-1515 mL in 1 CARTON; Type 0: Not a Combination Product05/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/29/2020
    HAND SANITIZER WIPES 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77848-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77848-001-1515 mL in 1 PACKET; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2020
    HAND SANITIZER WIPES 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77848-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    2-NITROPROPANE (UNII: GKV234L2QH)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CITRAL (UNII: T7EU0O9VPP)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77848-002-1515 mL in 1 PACKET; Type 0: Not a Combination Product05/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/29/2020
    Labeler - PDD Design LLC (065947601)
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