HAND SANITIZING GEL- instant hand sanitizing gel gel 
US Chemical Corporation

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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US Chem F056F

Directions Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol.

Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease, Recommended for repeated use.

Active Ingredient Ethyl Alcohol 62% v/v

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose Antibacterial Agent

Warnings Flammable. Keep away from fire or flame. For external use only. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop and ask a doctor if irritation or rash appears and persists.

Principal LabelPrincipal Dispaly

HAND SANITIZING GEL 
instant hand sanitizing gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-056
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
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 1342 (UNII: 809Y72KV36)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61307-056-311500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/07/2013
Labeler - US Chemical Corporation (031457842)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(61307-056)

Revised: 8/2023
Document Id: 03a8bd37-d222-2a2d-e063-6294a90a0406
Set id: a1880579-82b2-95d3-e053-2a95a90a733f
Version: 3
Effective Time: 20230824
 
US Chemical Corporation