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| Product NDC Code | 61924-106 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Gelrite |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | GEL | ||||||||||
| RxCUI drug identifier | 902574 | ||||||||||
| Application Number | M003 | ||||||||||
| Labeler Name | DERMARITE INDUSTRIES, LLC | ||||||||||
| 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 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 Wet hands thoroughly with product and allow to dry without wiping. Children under six should be supervised while using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Propylene Glycol, Carbomer, Polysorbate 20, Fragrance, t-Butanol, Triethanolamine, Tocopherol Acetate, Sodium Isostearoyl Lactate, Denatonium Benzoate
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 skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use. Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.GELRITE Hand Sanitizer ALCOHOL ALCOHOL WATER CARBOMER 940 DENATONIUM BENZOATE ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE PROPYLENE GLYCOL 1,2-DISTEARATE BUTANOL (MIXED ISOMERS) 2,4,5-T-TROLAMINE SODIUM ISOSTEAROYL LACTYLATE
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.GelRite Package Label Principal Display Panel Principal Display Panel
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 Keep out of reach of children. In case of accidental ingestion contact a physician or 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 Do not store above 105°F May discolor some fabrics or surfaces You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.
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 and flame. Avoid contact with eyes. In case of contact, flush thoroughly with water. Stop use and ask a doctor if skin irritation develops. .
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