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| Product NDC Code | 79116-000 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Naked x restore hand sanitizer |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 581662 | ||||||
| Application Number | part333E | ||||||
| Labeler Name | Essations Inc. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 70.0% v/v Purpose Antimicrobial
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 • Apply a generous amount to one palm. • Rub to saturate both palms. • Rub across back of hands, between fingers, & around thumbs covering all surafces until they feel dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D.I. Water (Aqua), Polysorbate-20, Fragrance, Carbomer, Triethanolamine.
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 handwashing to decrease bacteria on the skin. • Moisturinzing, cleansing solution. • Repeated use encouraged.
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.Naked X Restore Hand Sanitizer ALCOHOL WATER POLYSORBATE 20 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE ALCOHOL ALCOHOL
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.Package Labeling:64ml Label
Package Labeling:946ml Label2
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
Other information • Store at 20°C to 25°C (68°F to 77°F) • May discolor certain surfaces and fabrics.
Children under the age of 6 years old should be supervised when using this product. Do not use on children under 2 months of age, or on open skin 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, immediately seek medical attention or contact poison control.
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 and redness develop and persist for more than 72 hours.
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 heat, fire, and flame. Avoid contact with eyes, ears, and mouth. In case of eye contact, flush thoroughly with water for 10 minutes. Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours. Keep out of reach of children. If swallowed, immediately seek medical attention or contact poison control.
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