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Product NDC Code | 65601-700 | ||||||||||||
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Drug Name | Alcohol free foaming hand sanitizer |
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Type | Brand | ||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | SOAP | ||||||||||||
RxCUI drug identifier | 1020365 | ||||||||||||
Application Number | 505G(a)(3) | ||||||||||||
Labeler Name | Betco Corporation, Ltd. | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Alcohol Free Foaming Hand Sanitizer 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.Alcohol Free Foaming Hand Sanitizer Directions Read the entire label before using this product. Dispense 2 pumps of product onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Alcohol Free Foaming Hand Sanitizer Inactive Ingredients Deionized Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, PEG-3 Cocamide, Fragrance, Methyl Chloro Isothiazolinone, Methyl Isothiazolinone, D&C Green #5.
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.Alcohol Free Foaming Hand Sanitizer Uses Hand sanitizer to remove microorganisms on the skin. Use this product when soap and water are not available.
Purpose
Information about the drug product’s indications for use.Alcohol Free Foaming Hand Sanitizer Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Alcohol Free Foaming Hand Sanitizer Benzalkonium Chloride GRAPEFRUIT OIL BUTYLPHENYL METHYLPROPIONAL MAGNESIUM NITRATE .BETA.-CITRONELLOL, (+/-)- METHYLCHLOROISOTHIAZOLINONE CYCLOMETHICONE 4 ACETALDEHYDE GERANIOL HEXAMETHYLINDANOPYRAN DIHYDROMYRCENOL METHYL DIHYDROJASMONATE (SYNTHETIC) MYRCENE SODIUM PIDOLATE ISOPROPYL ALCOHOL N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) LINALOOL, (+/-)- ORANGE OIL D&C GREEN NO. 5 PEG/PPG-15/15 ALLYL ETHER ACETATE HEXYL SALICYLATE ALCOHOL LIME OIL METHYLISOTHIAZOLINONE WATER BENZALKONIUM CHLORIDE BENZALKONIUM DIOXANE PEG-6 COCAMIDE LEMON OIL
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.Alcohol Free Foaming Hand Sanitizer 53 29 88 04 55
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.Alcohol Free Foaming Hand Sanitizer KEEP OUT OF REACH OF CHILDREN
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Alcohol Free Foaming Hand Sanitizer Questions or Comments? Phone: (800) 777-9343 MDS information: (800) 891-4965
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.Alcohol Free Foaming Hand Sanitizer Warnings For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use is irritation or redness develops. If irritation persists for more than 72 hours, consult a physician. KEEP OUT OF REACH OF CHILDREN . If swallowed, get medical help or contact a 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