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Product NDC Code | 58400-010 | ||||||||||||||
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Drug Name | Hand sanitizer with aloe vera |
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Type | Brand | ||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||
Dosage Form | GEL | ||||||||||||||
RxCUI drug identifier | 581662 | ||||||||||||||
Application Number | M003 | ||||||||||||||
Labeler Name | Pharmco Laboratories, Inc. | ||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethyl Alcohol 70% v/v
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 Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Hydroxide
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
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer with aloe vera Alcohol Alcohol Alcohol Water Glycerin HYDROXYETHYL CELLULOSE, UNSPECIFIED Aloe Vera Leaf Citric Acid Monohydrate Sodium Hydroxide
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.PRINCIPAL DISPLAY PANEL - 59 mL Tube Label pharmco MANUFACTURER OF PREMIUM SKIN CARE PRODUCTS HAND SANITIZER with aloe vera 2 fl oz. (59 mL) PRINCIPAL DISPLAY PANEL - 59 mL Tube Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Manufactured by: Pharmco Laboratories, Inc. 3520 South St. Titusville, FL 32780
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 in children less that 2 months of age on open wounds
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 get medical help or call a poison control center 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.Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.
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, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store below 43°C (110°F) 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 fire or flame. Do not use in children less that 2 months of age on open wounds When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed get medical help or call 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