Otc - Active Ingredient
Chloroxylenol 0.1% w/w...........Antibacterial Handwashing
Soft And Silky Antiseptic Solution
FDA Label NDC 50865-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kutol Products Company, Inc. for the product Soft And Silky Antiseptic (NDC 50865-025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, warnings, dosage & administration, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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.
Otc - 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.
Package Label.Principal Display Panel
50865-025-65.jpg (50865 025 65)
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