SOFT AND SILKY ANTISEPTIC- antiseptic lotion soap solution

Soft and Silky Antiseptic by

Drug Labeling and Warnings

Soft and Silky Antiseptic by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc., Kutol Products Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Chloroxylenol 0.1% w/w...........Antibacterial Handwashing

INACTIVE INGREDIENT

Water, Tall Oil Acid, Potassium Hydroxide, Coconut Acid, Sodium Lauryl Sulfate, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Chloride, Styrene/Acrylates Copolymer, Fragrance, Iodopropynyl Butylcarbamate.

PURPOSE

Handwash to help decrease bacteria on the skin.

USDA E-1

WARNINGS

For external use only.

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

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

Handwash to help decrease bacteria on the skin.

USDA E-1

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

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

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

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.

PRINCIPAL DISPLAY PANEL

50865-025-65.jpg

INGREDIENTS AND APPEARANCE

SOFT AND SILKY ANTISEPTIC 
antiseptic lotion soap solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.82 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
TALL OIL (UNII: 1GX6Z36A79)
COCONUT ACID (UNII: 40U37V505D)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-025-03	208175 mL in 1 DRUM; Type 0: Not a Combination Product	11/04/2013
2	NDC: 50865-025-07	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/04/2013	05/10/2017
3	NDC: 50865-025-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/04/2013
4	NDC: 50865-025-12	1200 mL in 1 BAG; Type 0: Not a Combination Product	11/04/2013	05/10/2017
5	NDC: 50865-025-18	500 mL in 1 BAG; Type 0: Not a Combination Product	11/04/2013
6	NDC: 50865-025-65	800 mL in 1 BAG; Type 0: Not a Combination Product	11/04/2013
7	NDC: 50865-025-80	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/04/2013	05/10/2017
8	NDC: 50865-025-82	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/04/2013	05/10/2017
9	NDC: 50865-025-93	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/04/2013	05/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/04/2013

Labeler - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company Inc.		004236139	manufacture(50865-025) , analysis(50865-025) , label(50865-025) , pack(50865-025)