INSTANT HAND SANITIZER (GEL-TYPE)- instant hand sanitizer (gel-type) solution 
Tranzonic Companies

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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Instant Hand Sanitizer (Gel-Type)

Ethyl Alcohol 62% v/v.....Antibacterial Agent

Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Carbomer, Tocopheryl Acetate (Vitamin E), Aminomethyl Propanol

For hand cleaning to decrease bacteria on skin that could cause disease. Recommended for repeated use.

For external use only.

Flammable. Keep away from heat or flame.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, contact a physician or poison center. 

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

Children under 6 years of age should be supervised when using this product.

For hand cleaning to decrease bacteria on skin that could cause disease.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, contact a physician or poison center.

Keep out of reach of children. If swallowed, contact a physician or poison center.

53341-056-27.jpg 53341-056-27.jpg

INSTANT HAND SANITIZER (GEL-TYPE) 
instant hand sanitizer (gel-type) solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53341-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53341-056-27800 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/05/2013
Labeler - Tranzonic Companies (007900020)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(53341-056) , analysis(53341-056) , pack(53341-056)

Revised: 2/2014
Document Id: 01625d08-5cfd-45de-ac14-d3e6e637ed5e
Set id: b033876b-0638-4435-aa58-3c7b9cde1bd8
Version: 1
Effective Time: 20140227
 
Tranzonic Companies