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Product NDC Code | 69771-006 | ||||
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Drug Name | Tenderlaven hand |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 1549613 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Geri-Gentle Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Chloroxylenol 0.2% Purpose Antiseptic
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 and forearms. Apply 5 ml (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 15 seconds. Rinse and repeat.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water, sodium lauryl sulfate, Cocamide DEA, Cocamidopropyl Betaine, Glycerin, Citric Acid, Sodium chloride, Disodium EDTA, fragrance, Methylchloroisothiazolinone and Methylisothiazolinone, D&C Red NO.33, FD&C Blue NO.1
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: For handwashing to decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.TenderLaven Hand CHLOROXYLENOL WATER SODIUM LAURYL SULFATE COCO DIETHANOLAMIDE COCAMIDOPROPYL BETAINE GLYCERIN CITRIC ACID MONOHYDRATE SODIUM CHLORIDE EDETATE DISODIUM ANHYDROUS METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE D&C RED NO. 33 FD&C BLUE NO. 1 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.Package Labeling: Label2 Label3
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information: Store in a cool place away from direct sunlight.
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 except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use: if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.
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: Avoid contact with eyes. In case of contact, flush thoroughly with water. For external use only. Stop use: if irritation or redness develops. If condition persists for more than 72 hours consult a doctor. Keep out of reach of children except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center right away.
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