Label: HAND SANITIZER-SPRAY- alcohol spray

  • 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 July 15, 2020

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  • 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

    PEG-40 hydrogenated castor oil, Fragrance (Parfum), Tocopheryl acetate, Aloe barbadensis leaf extract, Phenoxyethanol, Ethylhexylglycerin, purified water USP

  • Package Label - Principal Display Panel

    60 mL NDC: 51706-814-01 Snoozy olive

    60 mL NDC: 51706-814-02 snoozy green

    60 mL NDC: 51706-814-03

    Snoozy blue

    60 mL NDC: 51706-814-04

    Snoozy pink

  • PRINCIPAL DISPLAY PANEL

    green60 mL NDC: 51706-815-01

    60 mL NDC: 51706-815-02 pink60 mL NDC: 51706-815-03 blue

    60 mL NDC: 51706-815-04 olive

  • PRINCIPAL DISPLAY PANEL

    60ml NDC 51706-816 5

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER-SPRAY 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-814
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0003 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-814-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:51706-814-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:51706-814-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:51706-814-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    HAND SANITIZER-SPRAY 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-816
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0003 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-816-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:51706-816-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:51706-816-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:51706-816-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    HAND SANITIZER-SPRAY 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-815
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0003 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-815-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:51706-815-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:51706-815-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:51706-815-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Snoozy Freshners, LLC075299630label(51706-814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-814, 51706-815, 51706-816)
    Establishment
    NameAddressID/FEIBusiness Operations
    DM imports, Ltd799543041label(51706-815)
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