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| Product NDC Code | 81286-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Palma hydrating hand sanitizing serum |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 581662 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | UNITRADE FZE | ||||
| 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 • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, caprylic/capric triglyceride, avocado ( Persea gratissima ) oil, propylene glycol, glycerin, jojoba ( Simmondsia chinensis ) seed oil, peg-40 hydrogenated castor oil, polyacrylamide, c13-14 isoparaffin, laureth-7, acrylates/c10-30 alkyl acrylates crosspolymer, niacinamide, sodium hyaluronate, tocopheryl acetate, panthenol, gotu kola ( Centella asiatica ) root extract, triethanolamine, fragrance.
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 decrease bacteria on the skin • recommended for repeated use • for use when 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.PALMA HYDRATING HAND SANITIZING SERUM Ethyl alcohol ALCOHOL ALCOHOL WATER MEDIUM-CHAIN TRIGLYCERIDES AVOCADO OIL PROPYLENE GLYCOL GLYCERIN JOJOBA OIL POLYOXYL 40 HYDROGENATED CASTOR OIL POLYACRYLAMIDE (1500 MW) C13-14 ISOPARAFFIN LAURETH-7 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) NIACINAMIDE HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE PANTHENOL CENTELLA ASIATICA ROOT TROLAMINE
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.Packaging PALMA -102
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
HYDRATING HAND SANITIZING SERUM WITH AVOCADO OIL, JOJOBA OIL, VITAMIN B3 & B5 Distributed by: Palma de Salus, Inc. 320 Old Country Road, Suite 205 Garden City, NY 11530, U.S.A. Made in U.A.E Designed in Los Angeles Please see the bottom of the bottle for Lot No & Expiry
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-516-808-0844 You may also report serious side effects to this phone number. Mon -Fri 9:00 AM to 5:00 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information • store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)
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/flame For external use only Do not use • in the eyes • on children less than 2 months of age • on open skin wounds When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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