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| Product NDC Code | 24330-412 | ||||
|---|---|---|---|---|---|
| Drug Name | Welmedix homecare pro fragile skin protectant |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 835547, 1427965 |
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| Application Number | M012 | ||||
| Labeler Name | Welmedix 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 ingredients Petrolatum 42%
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: For general skin protection: apply as needed. For incontinence care: change wet and soiled diapers and garments promptly. • Cleanse the affected area and allow to dry. • Apply ointment liberally, as often as necessary, especially at bedtime or any time when exposure to wet, moist or soiled garments may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, calendula oil, lanolin alcohol, dimethicone, glycerin, sorbitan sesquioleatem, aloe barbadensis leaf juice, hydrogenated coconut oil, hydrogenated lanolin, glyceryl stearate, phenoxyethanol, stearyl alcohol, cetyl alcohol, glycine soja (soybean) oil, mineral oil, ceresin
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 • temporarily protects and helps relieve chapped or cracked skin • helps protect from the drying effects of wind and cold weather • helps treat and prevent diaper rash • protects chafed skin associated with diaper rash and helps protect from wetness • temporarily protects: • minor cuts • scrapes • burns
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.Welmedix HomeCare PRO Fragile Skin Protectant Petrolatum PETROLATUM PETROLATUM ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER CERESIN CETYL ALCOHOL DIMETHICONE WATER GLYCERIN GLYCERYL MONOSTEARATE SOY STEROL HYDROGENATED COCONUT OIL LANOLIN LANOLIN ALCOHOLS MINERAL OIL PHENOXYETHANOL SORBITAN SESQUIOLEATE STEARYL ALCOHOL
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 PROTECTS + NOURISHES Hospital Grade Welmedix ® HomeCare PRO FRAGILE SKIN PROTECTIVE OINTMENT PETROLATUM 42% Protects fragile skin & creates an environment for healing Soothes and helps relieve dry, cracked and irritated skin Nourishes skin with Aloe, Calendula Oil and Coconut Oil Net Wt 5 oz (142g) Principal Display Panel - Carton 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.When using this product do not get into eyes
Other Information: Store at 20-25° C (68-77° F)
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.Do not use on • deep or puncture 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 If swallowed, get medical help or consult a Poison Control Center right away.
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.
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
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