SOFT AND SILKY ANTISEPTIC- antiseptic lotion soap solution 
Kutol Products Company, Inc.

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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F025F Soft and Silky Antiseptic

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

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

Handwash to help decrease bacteria on the skin.

USDA E-1

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.

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.

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

50865-025-65.jpg 50865-025-65.jpg

SOFT AND SILKY ANTISEPTIC 
antiseptic lotion soap solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.82 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-025-03208175 mL in 1 DRUM; Type 0: Not a Combination Product11/04/2013
2NDC:50865-025-073785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
3NDC:50865-025-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2013
4NDC:50865-025-121200 mL in 1 BAG; Type 0: Not a Combination Product11/04/201305/10/2017
5NDC:50865-025-18500 mL in 1 BAG; Type 0: Not a Combination Product11/04/2013
6NDC:50865-025-65800 mL in 1 BAG; Type 0: Not a Combination Product11/04/2013
7NDC:50865-025-80800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
8NDC:50865-025-82800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
9NDC:50865-025-931200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/04/2013
Labeler - Kutol Products Company, Inc. (004236139)
Registrant - Kutol Products Company (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company Inc.004236139manufacture(50865-025)

Revised: 8/2023
Document Id: 03376605-1ca8-91b4-e063-6394a90aa98d
Set id: 09d96b8d-be13-4295-8110-98dd82a454fa
Version: 5
Effective Time: 20230818
 
Kutol Products Company, Inc.