ANTIBACTERIAL HAND- antiseptic hand soap soap 
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 F060

Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients Water, Tall Oil Acide, Potassium Hydroxide, Coconut Acid, Phenoxyethanol, Cocamide DIPA, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Sodium Sulfate, Iodopropynl, Butylcarbamate, Yellow 5, Red 33.

Uses Handwash to help decrease bacteria on the skin.

Active Ingredient Chloroxylenol 0.3% w/w

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

Purpose Antibacterial Agent

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

Principal Label

ANTIBACTERIAL HAND 
antiseptic hand soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TALL OIL ACID (UNII: H9HR63474M)  
COCONUT ACID (UNII: 40U37V505D)  
ACID RED 35 (UNII: 02BXM5Q7GE)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61307-060-093785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/13/2013
Labeler - US Chemical Corporation (031457842)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company004236139manufacture(61307-060)

Revised: 8/2023
Document Id: 03a8bd37-d223-2a2d-e063-6294a90a0406
Set id: a18a50c0-49d2-1a96-e053-2995a90a29b5
Version: 7
Effective Time: 20230824
 
US Chemical Corporation