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| Product NDC Code | 0295-9011 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hydrolatum |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M016 | ||||||||
| Labeler Name | Denison Pharmaceuticals, 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.White Petrolatum, 54%
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.apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Methylparaben, Purified Water, Sorbitan Sesquioleate
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.temporarily protects and helps relieve chapped or cracked skin helps prevent and protect from the drying effects of wind and cold weather
Purpose
Information about the drug product’s indications for use.Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Hydrolatum White Petrolatum WATER SORBITAN SESQUIOLEATE PETROLATUM PETROLATUM METHYLPARABEN
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.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.deep or punctured wounds animal bites serious burns
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store at 20-25C (68-77F)
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.if condition lasts more than 7 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.do not get into eyes do not get into mouth
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.for external use only Keep out of reach of children Stop using if allergic
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