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| Product NDC Code | 63621-356 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sundrops 75 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | GEL | ||||||||||
| RxCUI drug identifier | 581658 | ||||||||||
| Application Number | 505G(a)(3) | ||||||||||
| Labeler Name | Sunburst Chemicals, 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 Ethyl Alcohol 60% 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 Place 5 grams or palmful of product in one hand. Spread on hands and run into skin until dry. Place a smaller amount (2.5 grams) in one hand and spread over both hands and wrists. Rub into skin until dry. Children should be supervised while using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Glycerin, Fragrance, Carbomer, Propylene Glycol, Diisopropylamine
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 amount of bacteria on the skin
Purpose
Information about the drug product’s indications for use.Purpose Skin Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.SunDrops 75 Alcohol GLYCERIN DIISOPROPYLAMINE ALCOHOL ALCOHOL WATER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) PROPYLENE GLYCOL water white - colorless, crystal clear
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 - 8 fl. oz. Bottle Top Label
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.
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. If swallowed, seek medical attention. When using this product do not use around or near the eyes. If contact occurs, flush eyes with water and contact doctor immediately. Stop use and consult a doctor when skin irritation appears and lasts. Keep out of reach of children.
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