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Product NDC Code | 78016-106 | ||||||||||||
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Drug Name | Klenlii hand antibacterial |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | SOAP | ||||||||||||
RxCUI drug identifier | 413261 | ||||||||||||
Application Number | M003 | ||||||||||||
Labeler Name | Klenlii Company | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT CHLOROXYLENOL 0.3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS WET HANDS APPLY A SMALL AMOUNT OF PRODUCT AND WORK INTO A LATHER RINSE WELL AND DRY HANDS COMPLETELY
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS DEIONIZED WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, AQUEOUS CATONIC COPOLYMER, CITRIC ACID
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN RECOMMENDED FOR REPEATED USE
Purpose
Information about the drug product’s indications for use.PURPOSE ANTIMICROBIAL
Spl product data elements
Usually a list of ingredients in a drug product.KLENLII HAND ANTIBACTERIAL CHLOROXYLENOL WATER SODIUM LAURETH SULFATE COCAMIDOPROPYL BETAINE BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) ANHYDROUS CITRIC ACID CHLOROXYLENOL CHLOROXYLENOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b LBL_Klenlii_Hand Sanii Soap_8oz
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS FOR EXTERNAL USE ONLY: HANDS WHEN USING THIS PRODUCT KEEP OUT OF AND AWAY FROM EYES IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER DO NOT INHALE OR INGEST STOP USE AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS CONDITION PERSISTS
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API