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| Product NDC Code | 61577-1112 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Los poblanos lavender 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 | part333A | ||||||||||||||
| Labeler Name | SOMBRA COSMETICS | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Ethyl Alcohol 65%
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 the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, lavandula angustifolia oil, lavandula hybrida (grosso) oil*, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract *organic
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 Helps reduce bacteria on the skin that could cause diseases.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.LOS POBLANOS LAVENDER HAND SANITIZER ALCOHOL ALCOHOL ALCOHOL WATER GLYCERIN ISOPROPYL ALCOHOL LAVANDULA ANGUSTIFOLIA FLOWER LAVANDIN OIL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) ROSA DAMASCENA FLOWER WITCH HAZEL
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.Los Poblanos 8oz gel
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 When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
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.
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 and 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 When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (105F)
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