Label: SOFT AND SILKY ANTISEPTIC- antiseptic lotion soap solution
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NDC Code(s):
50865-025-03,
50865-025-07,
50865-025-09,
50865-025-12, view more50865-025-18, 50865-025-65, 50865-025-80, 50865-025-82, 50865-025-93
- Packager: Kutol Products Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DOSAGE & ADMINISTRATION
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOFT AND SILKY ANTISEPTIC
antiseptic lotion soap solutionProduct 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 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 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) Registrant - Kutol Products Company (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company Inc. 004236139 manufacture(50865-025)
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