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Product NDC Code | 57337-021 | ||||
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Drug Name | Xtracare antibacterial hand cleanse original |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOAP | ||||
RxCUI drug identifier | 1020118 | ||||
Application Number | M003 | ||||
Labeler Name | Rejoice International, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Triclosan 0.15%........................Antibacterial
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 pump into hands lather vigorously for at least 15 seconds rinse and dry thoroughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, aloe barbadensis leaf juice, methylchloroisothiazolinone, methylisothiazolinone, fd&c yellow no.5, d&c red no. 33.
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 hand washing to decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Antibacterial Moisturizing Hand Soap Original Kills the germs Eliminates bacteria on hands Moisturizes the skin
Spl product data elements
Usually a list of ingredients in a drug product.XtraCare Antibacterial Hand Cleanse Original Triclosan WATER SODIUM C14-16 OLEFIN SULFONATE SODIUM LAURETH SULFATE COCO DIETHANOLAMIDE PEG-150 DISTEARATE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE GLYCERIN EDETATE DISODIUM ALOE VERA LEAF METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C YELLOW NO. 5 D&C RED NO. 33 TRICLOSAN TRICLOSAN
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.label image
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at room temperature DISTRIBUTED BY: REJOICE INTERNATIONAL, INC. 48325 BINGHAMPTON DR., NORTHVILLE, MI 48168, USA MADE IN CHINA
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. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask a doctor if irritation and redness develops.
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