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| Product NDC Code | 75540-528 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hyalolex hand sanitizer with lavender and zinc |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LIQUID | ||||||||||
| RxCUI drug identifier | 582753 | ||||||||||
| Application Number | part333E | ||||||||||
| Labeler Name | India Globalization Capital Inc | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Alcohol 70% v/v. Purpose: Antiseptic
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 with product and briskly rub hands together until dry. Supervise children under 6 years in use of this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, deionized water, Aloe Vera, Carbomer, Xanthan Gum, Zinc Oxide, Lavender Oil
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.Use To help reduce germs on the skin
Purpose
Information about the drug product’s indications for use.Purpose Hand Sanitizer, Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.Hyalolex Hand Sanitizer with Lavender and Zinc ALCOHOL ZINC ALUM XANTHAN GUM ALOE VERA LEAF LAVENDER OIL GLYCERIN CARBOMER 980 WATER 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.Hyalolex Hand Sanitizer wth Lavender and Zinc Sulfate and Paraben Free 70% Ethyl Alcohol Antimicrobial. Kills Germs Package Label - Principal Display Panel 236 mL 75540-528-08 472 mL 75540-528-16 3785 mL 75540-528-28 3785 mL Label 472 mL Label 236 mL Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Updated per the product label
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 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.
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 if irritation occurs
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. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 20C-25C (68F-77F) May discolor certain fabrics
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
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