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Product NDC Code | 51316-705 | ||||||
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Drug Name | Handsoap |
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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 | CVS Pharmacy Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Benzalkonium Chloride
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.Apply onto dry hands, work into a lather, rinse and dry throughly.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water( Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730).
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.Helps eliminate bacteria on the skin
Purpose
Information about the drug product’s indications for use.Antibacterial- Helps eliminate bacteria on hands.
Spl product data elements
Usually a list of ingredients in a drug product.Handsoap Benzalkonium chloride WATER HYDROXYETHYL CELLULOSE, UNSPECIFIED EDETATE SODIUM DIRECT BLUE 1 GREEN TEA LEAF METHYLISOTHIAZOLINONE SODIUM CITRATE CITRIC ACID MONOHYDRATE SULISOBENZONE METHYLCHLOROISOTHIAZOLINONE ALOE VERA LEAF PROPYLENE GLYCOL GLYCERIN EXT. D&C VIOLET NO. 2 POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) COCAMIDOPROPYL BETAINE FRAGRANCE CLEAN ORC0600327 POLYSORBATE 20 DECYL GLUCOSIDE 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.PDP 1 32oz
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.In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.
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.Avoid contact with eyes, If this occurs, rinse throughly with water.
Storage and handling
Information about safe storage and handling of the drug product.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.For external use only Avoid contact with eyes, If this occurs, rinse throughly with water. Stop use and ask a doctor if irritation or redness develops and lasts In case of accidental ingestion, seek medical attention or contact a poison control centre 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