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| Product NDC Code | 63621-353 | ||||
|---|---|---|---|---|---|
| Drug Name | Sundrops 67 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOAP | ||||
| RxCUI drug identifier | 1045003 | ||||
| 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 Chloroxylenol 0.75% w/w
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 and forearms. Apply a small amount (5 mL) or palmful to hands and forearms. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1
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 reduces amount of bacteria on hands
Purpose
Information about the drug product’s indications for use.Purpose Skin Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.SunDrops 67 Chloroxylenol CHLOROXYLENOL CHLOROXYLENOL WATER PROPYLENE GLYCOL FD&C BLUE NO. 1 TRIETHANOLAMINE LAURYL SULFATE LAURIC DIETHANOLAMIDE DMDM HYDANTOIN FD&C YELLOW NO. 5 green, dispensed as white foam
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.Case Label - 8 x 1000 mL Bags
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.Not for use on children under six months of age. For institutional and professional use only.
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. Do not use in eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician. Not for use on children under six months of age. For institutional and professional 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