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Product NDC Code | 72476-004 | ||||||||
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Drug Name | Careone amber |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SOAP | ||||||||
RxCUI drug identifier | 1046593 | ||||||||
Application Number | 505G(a)(3) | ||||||||
Labeler Name | Retail Business Services, LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient. Benzalkonium Chloride (0.13%)
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 apply onto wet hands (only for 222 ml and 333 ml) Lather and rinse thoroughly.(For all packages) From a pump bottle, apply onto wet hands (only for 1.66 L bottle) Use to refill a pump bottle (only for 1.66 L bottle)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).
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 Helps eliminate bacteria on hands.
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.Careone Amber Benzalkonium Chloride COCO MONOETHANOLAMIDE LAURAMIDOPROPYLAMINE OXIDE SODIUM CHLORIDE SODIUM SULFATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE FD&C RED NO. 40 WATER GLYCERIN CETRIMONIUM CHLORIDE PEG-120 METHYL GLUCOSE DIOLEATE FRAGRANCE CLEAN ORC0600327 CITRIC ACID MONOHYDRATE EDETATE SODIUM FD&C YELLOW NO. 5 D&C RED NO. 33 BENZALKONIUM CHLORIDE BENZALKONIUM
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.PDP2 PDP2
PDP3 PDP3
PDP4 PDP4
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. In case of accidental ingestion, get medical help or contact Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-877-846-9949
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 and ask a doctor. If irritation or redness develops and lasts
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product Avoid contact with eyes. In case of contact, rinse thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at Room Temperature
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 contact, rinse thoroughly with water. Stop use and ask a doctor. If irritation or redness develops and lasts Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately.
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