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Product NDC Code | 30805-015 | ||||||||||
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Drug Name | Altra non-alcohol foaming hand sanitizer with allantoin and aloe |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||
Dosage Form | SOLUTION | ||||||||||
Application Number | 505G(a)(3) | ||||||||||
Labeler Name | Buckeye International, Inc. | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium Chloride 0.12%
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 Dispense an adequate amount of hand sanitizer Rub hads together until completely dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Cocamidopropyl Betaine, Lauramine Oxide, Tetrasodium EDTA, Allantoin, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone
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 Hand sanitizer to help reduce bacteria on the skin that could cause disease Recommended for repeated use
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.Altra Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloe Benzalkonium Chloride METHYLCHLOROISOTHIAZOLINONE LAURAMINE OXIDE ALOE VERA LEAF ALLANTOIN COCAMIDOPROPYL BETAINE WATER EDETATE SODIUM METHYLISOTHIAZOLINONE 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.ALTRA Non-Alcohol Foaming hand Sanitizer with Allantoin and Aloe Hand Hygiene Manufactured by Buckeye International 2700 Wagner Place Maryland Heights MO 63043 USA (314) 291-1900 Product # 71151120 Net Contents 1250 mL (42.2 fl oz) container label
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, call a physician or 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? Call Buckeye International, Inc. 314-291-1900 Monday through Friday 8:00 a.m. to 5:00 p.m. CST
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.If irritation or rash appears and persists , stop use and see a physician.
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 do not use in or near eyes. If in eyes, flush thoroughly with water.
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 do not use in or near eyes. If in eyes, flush thoroughly with water. If irritation or rash appears and persists , stop use and see a physician. Keep out of reach of children. If swallowed, call a physician or 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