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Product NDC Code | 71706-060 | ||||||
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Drug Name | Benson bottom paint |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 1734937, 1946703 |
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Application Number | part346 | ||||||
Labeler Name | Benson's Bottom Paint , Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 22%
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 liberally apply Benson's Bottom Paint at first sign of redness or diaper rash daily until symptoms disappear. apply after each change, especially at bedtime or whenever exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Petrolatum, Stearyl Alcohol, Paraffin, Glycerin, Polysorbate 60, Sorbitan steareate, Polysorbate 20, Cetyl Alcohol, Emulsifying Wax, NF, Aminomethyl Propanol, Quaternium-15
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 To help promote healing of diaper rash To help prevent diaper rash Good for bedsores and blisters
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.Benson Bottom Paint Zinc Oxide Zinc Oxide Zinc Oxide Water Glycerin Aminomethylpropanol Polysorbate 20 Petrolatum Stearyl Alcohol Cetyl Alcohol Paraffin Sorbitan Monostearate Polysorbate 60 Polawax Polysorbate Quaternium-15 CIS-Form
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.PRINCIPAL DISPLAY PANEL - 170.1 gram Tube Label Benson's Bottom Paint Soothes and Promotes Healing ™ Pediatrician recommended Smooth, easy spreading No odor Isn't greasy Pharmacist formula net weight 6 ounces 170.1 grams PRINCIPAL DISPLAY PANEL - 170.1 gram Tube Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed in the U.S. by: BENSON'S BOTTOM PAINT, INC. P.O. Box 1531 • Muskegon, MI 49443-1531
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 . In case of accidental ingestion contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-637-3882
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 Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days
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 Do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20° to 30 ° C ( 68-86 °F) may stain clothing
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 When using this product Do not get into eyes Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children . In case of accidental ingestion contact a Poison Control Center immediately.
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