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Product NDC Code | 84853-0002 | ||||
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Drug Name | Hempz triple moisture moisturizing herbal hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | PBIGROUP, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Alcohol 63%
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 •Put enough product in your palm to cover hands and rub hands together briskly until dry. •Children under 6 years of age should be supervised when using.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Propanediol, Fragrance, Cannabis Sativa Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Mangifera Indica (Mango) Seed Butter, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Macrocystis Pyrifera (Kelp) Extract, Persea Gratissima (Avocado) Fruit Extract, Calendula Officinalis Flower Extract, Oryza Sativa (Rice) Extract, Silybum Marianum Seed Extract, Isopropyl Myristate, Benzyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Limonene, T-Butyl Alcohol, Aminomethyl Propanol, Linalool, Amyl Cinnamal, Hexyl Cinnamal, Denatonium Benzoate, Alcohol, Tocopherol
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 Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Hempz Triple Moisture Moisturizing Herbal Hand Sanitizer Alcohol TOCOPHEROL WATER GLYCERIN PROPANEDIOL CANNABIS SATIVA SEED OIL SUNFLOWER OIL MANGIFERA INDICA SEED BUTTER ALOE VERA LEAF COCONUT OIL CUCUMBER MACROCYSTIS PYRIFERA AVOCADO CALENDULA OFFICINALIS FLOWER RICE GERM SILYBUM MARIANUM SEED ISOPROPYL MYRISTATE BENZYL BENZOATE LIMONENE, (+)- TERT-BUTYL ALCOHOL AMINOMETHYLPROPANOL LINALOOL, (+/-)- .ALPHA.-AMYLCINNAMALDEHYDE .ALPHA.-HEXYLCINNAMALDEHYDE DENATONIUM BENZOATE 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 Label Principal Display Panel MI43727R2_20170007_250ML
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.SPL Unclassified • Paraben-Free • Gluten-Free • Cruelty-Free • 100% Vegan • THC-Free Kills 99.99% of germs, leaving hands soft and moisturized Distributed by: Hempz Dallas, TX 75248 800-851-4206 Made in U.S.A. © Hempz hempz.com 110-2275-03
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 contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information •Store below 110°F (43°C). May discolor certain fabrics or surfaces.
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? 800-851-4206 (USA only)
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 rash appears or lasts.
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 the eyes. In case of contact, rinse eyes 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 Flammable, keep away from fire or flame. For external use only.
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