ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel 
SJ Creations, Inc.

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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Drug Facts

Active Ingredient

ETHYL ALCOHOL 65%

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.


When using this product

Avoid contact with eyes. If contact occurs flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.


Keep out of the reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping. Repeat as necessary. Supervise children with use of this product.

Inactive Ingredients

Aminomethyl Propanol, Benzophenone-3, Carbomer, Deinized Aqua (water), Glycerin, Isopropyl Palmitate, Polyaminopropyl Biguanide, Propylene Glycol, Tocopheryll Acetate (Vitamin E).

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ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43269-910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43269-910-06236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/11/201501/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/11/201501/19/2023
Labeler - SJ Creations, Inc. (146379495)
Establishment
NameAddressID/FEIBusiness Operations
Tonic Bath and Body Products Shenzhen Ltd.528197042manufacture(43269-910)

Revised: 1/2023
 
SJ Creations, Inc.