VANILLA SKY HAND SANITIZER- alcohol gel 
Reaction Retail, LLC

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.

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Vanilla Sky Hand Sanitizer

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

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)

Revised: 8/2020
Document Id: ad137225-8fbc-2d06-e053-2995a90adc01
Set id: ad137225-8fbb-2d06-e053-2995a90adc01
Version: 1
Effective Time: 20200817
 
Reaction Retail, LLC