HAND SANITIZER FOAM- ethanol alcohol aerosol, foam 
PurCel Labs LLC

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Active Ingredient


Ethyl Alcohol 70% v/v


Purpose


Antiseptic


Uses


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


• On children less than 2 months of age.
• On open skin wounds.


When using this product do not use in or near the eyes. In case of contact, 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.


Directions


• Put enough product in your palm to cover hands and rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.


Other information


• Store below 110°F (43°C).
• Avoid freezing and excessive heat above 104°F (40°C).
• May discolor certain fabrics or surfaces.


Inactive ingredients


Water, Peg-10 Dimethicone, Aloe Barbadensis Extract, Glycerin, Propylene Glycol, Peg-7 Glyceryl Cocoate,
Tocopheryl Acetate.

83584-225-0183584-225-0283584-225-03

HAND SANITIZER FOAM 
ethanol alcohol aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83584-225
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83584-225-036 in 1 CARTON02/29/2024
1NDC:83584-225-022 in 1 BOX
1NDC:83584-225-011400 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00302/29/2024
Labeler - PurCel Labs LLC (127672531)
Registrant - PurCel Labs LLC (127672531)
Establishment
NameAddressID/FEIBusiness Operations
Zhongshan Dermey Commodity Co.,Ltd550280464manufacture(83584-225)

Revised: 3/2024
Document Id: 12eb53ff-a512-a834-e063-6294a90a88ba
Set id: 0e1f48d4-4cdc-7ebf-e063-6394a90a108b
Version: 5
Effective Time: 20240305
 
PurCel Labs LLC