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Product NDC Code | 57337-062 | ||||
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Drug Name | Xtracare wet wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 1043348 | ||||
Application Number | part333E | ||||
Labeler Name | Rejoice International | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Benzethonium Chloride 0.3% .............. 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 for adults and children 2 years and older apply to hands allow to dry without wiping ask a doctor before using on children under 2 years
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients water (aqua), ethyl alcohol, propylene glycol, PEG-40 hydrogenated castor oil, fragrance, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben
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.XtraCare Wet Wipes Antibacterial Fresh Citrus Scent Pocket Size Kills 99.9% of Germs
Purpose
Information about the drug product’s indications for use.Uses hand sanitizer to reduce bacteria on the skin.
Spl product data elements
Usually a list of ingredients in a drug product.XtraCare Wet Wipes Benzethonium Chloride WATER ALCOHOL PROPYLENE GLYCOL POLYOXYL 40 HYDROGENATED CASTOR OIL EDETATE DISODIUM ALOE VERA LEAF METHYLPARABEN PROPYLPARABEN BENZETHONIUM CHLORIDE BENZETHONIUM
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Questions/comments? 1-855-345-5575 DISTRIBUTED BY REJOICE INTERNATIONAL INC 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. Do not use if you are allergic to any of the ingredients. When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if irritation and redness develops, and continues for more than 72 hours.
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