Label: GEL HAND SANITIZER WINTERGREEN- alcohol 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 October 13, 2020

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  • Active Ingredient(s)

    Alcohol 65% Active ingredient

  • Purpose

    PurposeAntiseptic, Hand Sanitizer

  • Use

    To reduce bacteria on hands. UsesFor use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame, do not use on open wounds, avoid eyes, ears and mouth. In case of contact, rinse with water Warnings

    Stop use and ask a doctor if irritation or rash occurs., you may report side effects 1-800-315-4467 Stop and ask doctor if

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
    • Do not use on children less than two months of age
      Directions
  • Other information

    • Other information
      Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    acrylate polymer, bittering agent, fragrance, Inactive ingredientsglycerin, hydrogen peroxide, polyethylene glycol, water

  • Questions

    Questions

    1-800-315-4467, Monday Through Friday 8am-5pm

  • Package Label - Principal Display Panel

    Front Label

  • INGREDIENTS AND APPEARANCE
    GEL HAND SANITIZER WINTERGREEN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75660-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) 0.5 mL  in 100 mL
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.01 mL  in 100 mL
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.35 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.18 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 30.95 mL  in 100 mL
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 2 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75660-124-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    2NDC:75660-124-044 in 1 BOX10/13/2020
    2NDC:75660-124-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:75660-124-0518927.05 mL in 1 CONTAINER; Type 0: Not a Combination Product10/13/2020
    4NDC:75660-124-066 in 1 BOX10/13/2020
    4NDC:75660-124-013785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:75660-124-44118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    6NDC:75660-124-08236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    7NDC:75660-124-16473.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/13/2020
    8NDC:75660-124-259463.52 mL in 1 CONTAINER; Type 0: Not a Combination Product10/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/13/2020
    Labeler - Sovents and Petroleum Inc (013277454)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clean All117505240manufacture(75660-124)
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