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| Product NDC Code | 63148-516 | ||||||||||||||||
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| Drug Name | Natural concepts hand sanitizer |
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| Type | Brand | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | GEL | ||||||||||||||||
| RxCUI drug identifier | 902574 | ||||||||||||||||
| Application Number | part333E | ||||||||||||||||
| Labeler Name | Apollo Health and Beauty Care Inc. | ||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 65% Purpose Antiseptic
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 Adults only For occasional and personal use Rub thoroughly into hands for at least 30 seconds. Allow to dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer
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 for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Natural Concepts Hand Sanitizer Ethyl Alcohol ALCOHOL ALCOHOL WATER POLYETHYLENE GLYCOL 300 ISOPROPYL ALCOHOL GLYCERIN ISOPROPYL MYRISTATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, DL-
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 copy image of the label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on children less than 2 month of age on open skin wounds on broken or damaged skin if you are pregnant or breastfeeding 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 a Poison Control Center immediately.
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 a 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? 1-866-695-3030
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 Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
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. If contact occurs, rinse eyes thoroughly with water. Do not inhale. Do not use on children less than 2 month of age on open skin wounds on broken or damaged skin if you are pregnant or breastfeeding 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 a Poison Control Center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at a temperature below 110°F (43°C) may discolor certain fabrics or surfaces
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 flammable keep away from source of heat or fire When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale. Do not use on children less than 2 month of age on open skin wounds on broken or damaged skin if you are pregnant or breastfeeding 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 a 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