ANTIBACTERIAL HAND- antiseptic hand soap soap

Antibacterial Hand by

Drug Labeling and Warnings

Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by US Chemical Corporation, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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 INGREDIENT

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.

INDICATIONS & USAGE

Uses Handwash to help decrease bacteria on the skin.

ACTIVE INGREDIENT

Active Ingredient Chloroxylenol 0.3% w/w

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose Antibacterial Agent

WARNINGS

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 DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND 
antiseptic hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61307-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM SULFATE (UNII: 0YPR65R21J)
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)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61307-060-09	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/13/2013

Labeler - US Chemical Corporation (031457842)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	manufacture(61307-060)