Label: BURGER TIME HAND SANITIZER- alcohol liquid
FRESH FRIES HAND SANITIZER- alcohol liquid
PIZZA PARTY HAND SANITIZER- alcohol liquid
SPARKLED DONUT HAND SANITIZER- alcohol 62% 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 April 24, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ethyl Alcohol  62%

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use hand sanitizer to help reduce bacteria on skin.

  • Warning

    Flammable Keep away from heat and flame

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask doctor if irritation or redness develops

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ Wet hands thoroughly with product and rub into skin until dry.
    ■ Children Directions
    ■ Wet hands thoroughly with product and rub into skin until dry.
    ■ Children under 6 years of age should be supervised by an
    adult when using.

  • INACTIVE INGREDIENT

    Inactive
    Ingredients
    Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance,
    Glycerin, Propylene Glycol, Triethanolamine, Tocopheryl Acetate
    FD&C Yellow No. 5, FD&C Blue No. 1

  • Product Labels for: Burger Time  Fresh Fries  Pizza Party  Sparkled Donut

    Burger Time Hand Sanitizer Label

    Burger Time

    HAND SANITIZER

    Drug Facts

    Active
    Ingredients
    Ethyl Alcohol 62.0%

    Purpose
    Antimicrobial

    Use hand sanitizer
    to help reduce
    bacteria on skin.

    ADDITIONAL DRUG FACTS

    Distributed By:
    Personal Care Products, LLC
    Troy, Michigan 48084
    Made in China

    Drug Facts
    (continued)

    Flammable Keep
    away from heat and
    flame

    When using this
    product avoid contact
    with eyes. If contact
    occurs, rinse
    thoroughly with water.

    Stop use and ask
    doctor if irritation or
    redness develops

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

    Drug Facts
    (continued)

    Directions
    ■ Wet hands
    thoroughly with
    product and rub
    into skin until dry.
    ■ Children under
    6 years of age
    should be
    supervised by an
    adult when using.

    Inactive
    Ingredients
    Water (Aqua), Aloe
    Barbadensis Leaf Juice,
    Carbomer, Fragrance,
    Glycerin, Propylene
    Glycol, Triethanolamine,
    Tocopheryl Acetate
    FD&C Yellow No. 5,
    FD&C Blue No. 1

    BrgrTime

    Fresh Fries Hand Sanitizer Label

    FreshFries

    Pizza Party Hand Sanitizer Label

    PizzaParty


    Sparkled Donut Hand Sanitizer Label

    SparkldDonut

  • INGREDIENTS AND APPEARANCE
    BURGER TIME  HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL17.57 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9413-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2018
    FRESH FRIES  HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL17.57 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9414-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2018
    PIZZA PARTY  HAND SANITIZER
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL17.57 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9415-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2018
    SPARKLED DONUT  HAND SANITIZER
    alcohol 62% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-9416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL17.57 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-9416-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2018
    Labeler - GL 360 (966155082)
    Registrant - GL 360 (966155082)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!