Label: BABINGTONSOAPCO- hand sanitizer gel 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 2, 2020

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  • Active Ingredient(s)

    Alcohol 66% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    Flammable. Keep away from fire or flame

    For external use only.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Dispense onto dry hands and rub together thoroughly and then allow product to dry without rinsing. Do not use on open skin or wounds.
    • Not for use by children under 6 years old.
  • Other information

    • Do not store above 106F.
    • If skin irritation or rash occurs discontinue use immediately.
    • May discolor some fabrics.
  • Inactive ingredients

    Aqua, Polyquaternium 10, Chitosan, lactic acid organic, lemongrass oil.

  • Package Label - Principal Display Panel

    55 mL NDC: 80104-111-1155 mL NDC: 80104-111-11

  • INGREDIENTS AND APPEARANCE
    BABINGTONSOAPCO 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80104-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYQUATERNIUM-10 (20000 MPA.S AT 2%) (UNII: N2GK4S7X4T)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    WATER (UNII: 059QF0KO0R)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80104-111-1155 mL in 1 BOTTLE; Type 0: Not a Combination Product12/02/2020
    2NDC:80104-111-12250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/02/2020
    Labeler - Babington Soap Co Limited (226050699)
    Establishment
    NameAddressID/FEIBusiness Operations
    George K Hood Legacy LLP122360994manufacture(80104-111)
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