Label: VANILLA SKY HAND SANITIZER- 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 August 17, 2020

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  • Drug Facts

  • Active Ingredient:

    Ethyl Alcohol 75%

    Antiseptic

  • Uses:

    Hand sanitizer to help decrease bacteria on the skin.

  • Warnings:

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

    Stop use and ask doctor if

    irritation or rash appears and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a doctor right away.

  • Directions:

    Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

  • Other Information: 

    Store below 118 F

  • Inactive Ingredients:

    Aqua (Water), Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Parfum (Fragrance), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Citric Acid, Potassium Sorbate, Sodium Benzoate, Sucrose, Zea Mays (Corn) Starch, Hydroxypropyl Methylcellulose, Polyvinyl Alcohol, Benzyl Benzoate, Hexyl Cinnamal, Limonene, Butylphenyl Methylpropional, Linalool, CI 77267 (D&C Black No. 3), CI 60730 (Ext. D&C Violet No.2).

  • Package Labeling:

    Label11

  • INGREDIENTS AND APPEARANCE
    VANILLA SKY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80026-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    CORN (UNII: 0N8672707O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    D&C BLACK NO. 2 (UNII: 4XYU5U00C4)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80026-004-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/15/2020
    Labeler - Reaction Retail, LLC (968085212)
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