Label: HAND SANITIZER- alcohol liquid

  • 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 June 1, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Alcohol 65% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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 or rash occurs. These may be signs of a serious condition.
    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 or rash occurs. These may be signs of a serious condition.

  • 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

    • 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.
  • Other information

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

    Bergamot Essential Oil, Fragrance (Essential Oil Blend), Organic Aloe barbadensis Leaf Juice, Organic Glycerin (Flax Seed), Purified Water.

  • Package Label - Principal Display Panel

    2 fl. oz. (60 mL) NDC: 79965-007-00

    79965-007-00

    4 fl. oz. (120 mL) NDC: 79965-007-01

    79965-007-01

    2 fl. oz. (60 mL) NDC: 79965-107-00

    79965-107-00

    4 fl. oz. (120 mL) NDC: 79965-107-01

    79965-107-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79965-107
    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
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    BERGAMOT OIL (UNII: 39W1PKE3JI) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 31.68 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.02 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79965-107-0060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2021
    2NDC:79965-107-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2021
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79965-007
    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
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    BERGAMOT OIL (UNII: 39W1PKE3JI) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 31.68 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.02 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79965-007-0060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2021
    2NDC:79965-007-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2021
    Labeler - Neptune Health & Wellness Innovation (117560399)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(79965-007, 79965-107) , label(79965-007, 79965-107) , pack(79965-007, 79965-107)